Trial: A Study of Disitamab Vedotin Alone or W…

Trial Details

Sponsor: Seagen, a wholly owned subsidiary of Pfizer (industry)

Phase: 2

Start date: May 3, 2022

Planned enrollment: 372

Trial ID: NCT04879329

More trial details at ClinicalTrials.gov

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: disitamab vedotin (RC48, Aidixi)

Disitamab vedotin (RC48, Aidixi) is an antibody-drug conjugate (ADC) that targets HER2-expressing cancers. It consists of a humanized anti-HER2 monoclonal antibody (disitamab) conjugated to the cytotoxic agent monomethyl auristatin E (MMAE) via a cleavable vedotin linker [1]. The drug works through multiple mechanisms including direct cytotoxicity to HER2-expressing cells, bystander effect on neighboring cells, immunogenic cell death, and inhibition of HER2 signaling pathways. It received its first approval in China in June 2021 for HER2-overexpressing locally advanced or metastatic gastric cancer after at least two lines of chemotherapy [2].

Clinical Efficacy and Safety

Clinical trials have shown promising results across multiple cancer types. In HER2-expressing metastatic breast cancer, the drug demonstrated objective response rates of 42.9% in HER2-overexpressing and 33.3% in HER2-low disease, with median progression-free survival of 5.7 and 5.1 months respectively [3]. In urothelial carcinoma, when combined with the immunotherapy drug toripalimab, it showed a 73.2% response rate with median progression-free survival of 9.2 months [4]. Common adverse events include elevated liver enzymes, peripheral neuropathy, asthenia, and neutropenia. Grade 3 or higher adverse events occurred in about 40-44% of patients across trials, but were generally manageable.

The drug is currently being investigated in multiple ongoing clinical trials, including phase 3 studies in various cancers. It is being studied both as monotherapy and in combination with other agents like immunotherapy drugs and targeted therapies. Development is focused on both HER2-overexpressing and HER2-low expressing cancers, with studies ongoing in breast cancer, gastric cancer, urothelial cancer, and other solid tumors.

Sources:

[1] AACR Abstract on Mechanism of Action [2] Review Article on Development and Approval [3] Phase I/Ib Study in Breast Cancer [4] Phase 1b/2 Study in Urothelial Cancer

Last updated: Dec 2024

HealthScout AI Analysis

Goal: Evaluate the antitumor activity and safety of the HER2-targeted antibody-drug conjugate disitamab vedotin (DV), alone or combined with pembrolizumab, in HER2-expressing locally advanced unresectable or metastatic urothelial carcinoma, and characterize pharmacokinetics and immunogenicity.

Patients: Adults with histologically confirmed locally advanced, unresectable or metastatic urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra with centrally confirmed HER2 expression (IHC 1+, 2+, or 3%). Multiple cohorts enroll patients across lines of therapy: previously treated (1–2 prior lines including platinum; or prior enfortumab vedotin ± pembrolizumab), treatment-naïve but cisplatin/carboplatin-eligible, and Japan-specific cohorts with mandated prior exposure to platinum, PD-(L)1 inhibitors, and enfortumab vedotin. ECOG 0–1 for most cohorts (0–2 allowed in one first-line cohort). Key exclusions include prior HER2-directed therapy, prior MMAE-based ADCs in most cohorts, unresolved toxicities, significant neuropathy, and recent major surgery; immune therapy–related exclusions apply when pembrolizumab is used.

Design: Phase 2, multi-cohort, open-label, multicenter study with both randomized and non-randomized components. Randomization occurs within Cohort C comparing DV plus pembrolizumab versus DV monotherapy in the first-line, chemotherapy-eligible setting. Other cohorts are single-arm. Planned enrollment is 372.

Treatments: Disitamab vedotin (RC48-ADC) is a HER2-targeted antibody-drug conjugate composed of a humanized anti-HER2 antibody linked via a cleavable vedotin linker to the microtubule-disrupting payload monomethyl auristatin E (MMAE). Mechanisms include targeted delivery of MMAE to HER2-expressing cells, bystander cytotoxicity, immunogenic cell death, and HER2 signaling inhibition. Across early-phase studies in HER2-expressing solid tumors, DV has shown meaningful activity, including objective responses in urothelial carcinoma (notably high response rates when combined with PD-1 blockade) and manageable toxicity characterized by neuropathy, cytopenias, and transaminase elevations. Pembrolizumab is an anti–PD-1 monoclonal antibody used as standard immunotherapy in urothelial carcinoma; in this trial it is combined with DV in selected cohorts to assess potential synergy.

Outcomes: Primary endpoints: confirmed objective response rate by blinded independent central review in most cohorts (A, B, C, G); in Japan-only cohorts (D, E), primary endpoints are safety-focused, including incidence of adverse events, dose alterations, laboratory and ECG abnormalities, LVEF changes, and DV pharmacokinetics (AUC, Cmax, Tmax, Ctrough). Secondary endpoints across cohorts include investigator-assessed ORR, duration of response, progression-free survival, disease control rate, overall survival, safety/tolerability summaries, ECG and LVEF changes, DV and pembrolizumab pharmacokinetics, and anti-drug and neutralizing antibody incidence. Follow-up for efficacy extends approximately 2 years, with survival up to about 3 years.

Burden on patient: Moderate to high. Participants will undergo frequent clinic visits for intravenous infusions (DV with or without pembrolizumab), serial safety assessments, and regular imaging per RECIST. Central confirmation of HER2 status implies provision of adequate tumor tissue; new biopsy may be required if archival tissue is insufficient. Early-cycle intensive pharmacokinetic sampling is planned, especially in Japan cohorts, along with periodic ECGs and echocardiograms/MUGA to monitor LVEF, increasing visit length and blood draw frequency. Monitoring for neuropathy and immune-related adverse events (in combination cohorts) necessitates additional evaluations and potential dose modifications. Travel burden is consistent with multi-center oncology trials using IV therapies and frequent assessments over approximately 2 years.

Eligibility

Show Criteria

Inclusion Criteria:

Cohorts A and B

* Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra

* Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of platinum-containing chemotherapy

* At least one measurable lesion by investigator assessment based on RECIST version 1.1.

* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample

* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Cohort C

* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra

* No prior systemic therapy for LA/mUC

* Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy

* At least one measurable lesion by investigator assessment based on RECIST v1.1.

* Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation

* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, on the provided tumor tissue sample

* ECOG performance status of 0, 1, or 2

Cohort D

* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra

* Based on a participant's eligibility to receive treatment with standard of care therapies in Japan, participants must have received all of the following lines of therapy for LA/mUC:

* a. One prior line of platinum-containing chemotherapy.

* b. Prior therapy with PD-(L)1 inhibitors as (neo)adjuvant therapy, first-line maintenance therapy or as second line treatment.

* c. Prior enfortumab vedotin therapy.

* At least one measurable lesion by investigator assessment based on RECIST v1.1.

* ECOG performance status of 0 or 1

Cohort E

* Histopathologically-confirmed LA/mUC, including UC originating from the renal pelvis, ureters, bladder, or urethra

* No prior systemic therapy for LA/mUC

* Neoadjuvant or adjuvant therapy, including PD-(L)1 inhibitors, is acceptable, if disease recurrence/progression occurred more than 12 months after the last dose of systemic therapy.

* At least one measurable lesion by investigator assessment based on RECIST v1.1.

* Participant is eligible to receive cisplatin- or carboplatin- containing chemotherapy per investigator evaluation

* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample

* ECOG performance status of 0 or 1

Cohort G

* Histopathologically-confirmed, locally-advanced, unresectable or metastatic urothelial cancer (LA/mUC), including UC originating from the renal pelvis, ureters, bladder, or urethra

* Participants must have received only 1 or 2 lines of prior systemic treatment for LA/mUC, including 1 line of therapy containing enfortumab vedotin as monotherapy or in combination with pembrolizumab

* The last administration of enfortumab vedotin must be 90 days from the start of study treatment. Intervening therapies are allowed between the final dose of enfortumab vedotin and the start of disitamab vedotin.

* At least one measurable lesion by investigator assessment based on RECIST version 1.1.

* HER2-expression status determined by the central laboratory to be IHC 1+, 2+ or 3+, in the provided tumor sample

* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

Cohorts A and B

* Known hypersensitivity to disitamab vedotin or any of their components

* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohorts A and B)

* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)

* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy

* Major surgery that has not fully recovered within 4 weeks prior to dose administration

* Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline

Cohort C

* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components

* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study defined as Cycle 1 Day 1 for the single-arm part of Cohort C and as randomization date for the randomized part of Cohort C)

* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)

* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy

* Major surgery that has not fully recovered within 4 weeks prior to dose administration

* Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline

* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug

* Participants who have previously received any prior treatment with an agent directed to another stimulatory or co-inhibitory T cell receptor (including but not limited to CD137 agonists, CAR-T cell therapy, CTLA-4 inhibitors, or OX-40 agonists) are excluded.

Cohort D

* Known hypersensitivity to disitamab vedotin or any of their components

* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort D)

* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)

* Prior HER2-directed therapy

* Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy

* Major surgery that has not fully recovered within 4 weeks prior to dose administration

* Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline

Cohort E

* Known hypersensitivity to disitamab vedotin, pembrolizumab, or any of their components

* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort E)

* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)

* Any prior history of ≥ Grade 3 non-hematological AEs related to prior therapy

* Prior MMAE-based ADCs (eg, enfortumab vedotin) or HER2-directed therapy

* Major surgery that has not fully recovered within 4 weeks prior to dose administration

* Peripheral sensory or motor neuropathy ≥ Grade 1 at baseline

Cohort G

* Known hypersensitivity to disitamab vedotin or any of their components

* Prior antitumor treatment (including chemotherapy, radiotherapy, targeted therapy, immunotherapy etc.) within 2 weeks of start of study (defined as Cycle 1 Day 1 for Cohort G)

* Toxicity from a previous treatment has not returned to Grades 0 or 1 (except for Grade 2 alopecia)

* Prior HER2-directed therapy

* Major surgery that has not fully recovered within 4 weeks prior to dose administration

* Peripheral sensory or motor neuropathy ≥ Grade 2 at baseline

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Sites (178)

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Clinica Viedma

Viedma, Río Negro Province, R8500ACE, Argentina

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Status: Recruiting

Instituto Medico Especializado Alexander Fleming

Buenos Aires, C1426ANZ, Argentina

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Hospital Aleman

Buenos Aires, C1118AAT, Argentina

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Hospital Sirio Libanes - Buenos Aires

Buenos Aires, ZC 1419, Argentina

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Instituto Oncologico de Cordoba

Córdoba, X5004, Argentina

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Centro Oncologico Korben

Caba, ZC 1426, Argentina

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Status: Not yet recruiting

Centro Medico Austral

CABA, C1019ABS, Argentina

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Fundacion Cenit

CABA, 1125, Argentina

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GenesisCare - North Shore

St Leonards, New South Wales, 2065, Australia

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Macquarie University

Sydney, New South Wales, 2109, Australia

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Mater Cancer Care Centre, Mater Misericordiae Limited

South Brisbane, Queensland, QLD 4101, Australia

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Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, 3199, Australia

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Princess Alexandra Hospital

Woolloongabba, 4102, Australia

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Lyell McEwin Hospital

Elizabeth Vale, 5112, Australia

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Status: Recruiting

CHU UCL Namur-Site de Saint Elisabeth

Namur, 5000, Belgium

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Status: Active, not recruiting

AZ Maria Middelares

Ghent, 9000, Belgium

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Status: Active, not recruiting

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, T3N 4N1, Canada

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Status: Recruiting

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

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BC Cancer - Vancouver Fairmont Medical Building

Vancouver, British Columbia, V5Z 1H7, Canada

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CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

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Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

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Centre Hospitalier Universitaire de Sherbrooke

Fleurimont, Canada

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Status: Recruiting

Pontificia Universidad Catolica de Chile

Santiago, Providencia, 8330032, Chile

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Oncovida SA

Santiago, Providencia, 7510032, Chile

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Status: Recruiting

IC La Serena Research SpA

La Serena, CP 1720430, Chile

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Status: Recruiting

The Chaim Sheba Medical Center

Ramat Gan, 5265601, Israel

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Status: Active, not recruiting

Sheba Medical Center

Ramat Gan, 52621, Israel

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Status: Active, not recruiting

Rabin medical Center

Petah Tikva, 4941492, Israel

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Status: Active, not recruiting

Rambam Health Care Campus

Haifa, 3109601, Israel

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Status: Active, not recruiting

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

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Status: Active, not recruiting

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

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Status: Active, not recruiting

Centro di Riferimento Oncologico Di Aviano

Aviano, Pordenone, 33184, Italy

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Status: Active, not recruiting

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, ROME, 00168, Italy

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Status: Active, not recruiting

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

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Status: Active, not recruiting

S.C. Farmacia Interna

Terni, 05100, Italy

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Status: Active, not recruiting

Azienda Ospedaliera S. Maria di Terni

Terni, 05100, Italy

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Status: Active, not recruiting

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

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Status: Active, not recruiting

IOV-Istituto Oncologico Veneto IRCCS-U.O. Oncologia Medica 1-SC Farmacia

Padua, 35128, Italy

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Status: Active, not recruiting

IRCCS Ospedale San Raffaele, U.O. Farmacia Studi Clinici

Milan, 20132, Italy

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Status: Active, not recruiting

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

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Status: Active, not recruiting

Sapporo Medical University Hospital

Sapporo, Hokkaido, 060-8543, Japan

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Status: Active, not recruiting

Osaka University Hospital

Suita-shi, Osaka, 565-0871, Japan

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Status: Active, not recruiting

Tokushima University Hospital

Tokushima, Tokushima, 770-8503, Japan

No email / No phone

Status: Recruiting

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

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Status: Active, not recruiting

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, 541-8567, Japan

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Status: Active, not recruiting

Hospital Universitari Parc Tauli Sabadell

Sabadell, Barcelona, 08208, Spain

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Status: Active, not recruiting

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

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Status: Active, not recruiting

MD Anderson Cancer Center Madrid

Madrid, 28033, Spain

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Status: Active, not recruiting

MD Anderson Cancer Center - Madrid

Madrid, 28033, Spain

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Status: Active, not recruiting

Hospital Universitari Vall d'Hebrón

Barcelona, 08035, Spain

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Status: Active, not recruiting

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

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Status: Recruiting

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

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Status: Not yet recruiting

The Christie NHS Foundation Trust - Christie Hospital

Manchester, M20 4BX, United Kingdom

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Status: Not yet recruiting

The Clatterbridge Cancer Centre NHS Foundation Trust, The Clatterbridge Cancer Centre - Wirral

Merseyside, CH63 4JY, United Kingdom

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Status: Recruiting

Charing Cross Hospital

London, W6 8RF, United Kingdom

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Status: Recruiting

Barts Health NHS Trust, St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

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Status: Recruiting

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

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Status: Recruiting

Guy's Hospital

London, SE1 9RT, United Kingdom

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Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

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Banner Gateway Medical Center

Gilbert, Arizona, 85234, United States

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Status: Recruiting

UCSF Cancer Center MZ Phlebotomy

San Francisco, California, 94115, United States

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Status: Recruiting

Kaiser Permanente Anaheim Kraemer Medical Offices

Anaheim, California, 92806, United States

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Kaiser Permanente Baldwin Park Medical Center

Baldwin Park, California, 91706, United States

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Kaiser Permanente Bellflower Medical Offices

Bellflower, California, 90706, United States

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Status: Recruiting

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, 91010, United States

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Status: Active, not recruiting

Kaiser Permanente Fontana Medical Center

Fontana, California, 92335, United States

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Status: Recruiting

Kaiser Permanente South Bay Medical center

Harbor City, California, 90710, United States

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Status: Recruiting

Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

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Status: Recruiting

Kaiser Permanente Alton/Sand Canyon Medical Offices

Irvine, California, 92618, United States

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Kaiser Permanente Los Angeles Medical Offices

Los Angeles, California, 90027, United States

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Status: Recruiting

Kaiser Permanente West Los Angeles Medical Center

Los Angeles, California, 90034, United States

No email / No phone

Status: Recruiting

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

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Status: Not yet recruiting

Ronald Reagan UCLA Medical Center, Drug Information Center

Los Angeles, California, 90095, United States

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Status: Recruiting

UCLA Hematology Oncology

Los Angeles, California, 90095, United States

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Status: Recruiting

Kaiser Permanente Ontario Medical Center

Ontario, California, 91761, United States

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Status: Recruiting

UC Irvine Health

Orange, California, 92868, United States

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Status: Recruiting

Kaiser Permanente Panorama City Medical Center, Medical Offices 3

Panorama City, California, 91402, United States

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Status: Recruiting

Kaiser Permanente Riverside Medical Center

Riverside, California, 92505, United States

No email / No phone

Status: Recruiting

Southern California Permanente Medical Group (SCPMG)

Riverside, California, 92505, United States

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Status: Recruiting

Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)

San Diego, California, 92108, United States

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Status: Recruiting

Kaiser Permanente Zion Medical Center

San Diego, California, 92120, United States

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Status: Recruiting

UCSF Mount Zion Phlebotomy

San Francisco, California, 94115, United States

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Status: Recruiting

UCSF Parnassus Phlebotomy

San Francisco, California, 94143, United States

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Status: Recruiting

UCSF Investigational Drugs Pharmacy

San Francisco, California, 94158, United States

No email / No phone

Status: Recruiting

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

San Francisco, California, 94158, United States

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Status: Recruiting

University of California, San Francisco

San Francisco, California, 94158, United States

No email / No phone

Status: Recruiting

Kaiser Permanente San Marcos Medical Offices

San Marcos, California, 92078, United States

No email / No phone

Status: Recruiting

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California, 90404, United States

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Status: Recruiting

Kaiser Permanente Woodland Hills Medical Center

Woodland Hills, California, 91367, United States

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Status: Recruiting

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

No email / No phone

Status: Not yet recruiting

Florida Cancer Specialists

Bonita Springs, Florida, 34135, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Bradenton, Florida, 34205, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Bradenton, Florida, 34211, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Cape Coral, Florida, 33909, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Daytona Beach, Florida, 32117, United States

No email / No phone

Status: Active, not recruiting

Florida Cancer Specialists

Fleming Island, Florida, 32003, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Fort Myers, Florida, 33905, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Fort Myers, Florida, 33908, United States

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Status: Recruiting

Florida Cancer Specialists

Naples, Florida, 34102, United States

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Status: Recruiting

Florida Cancer Specialists

Port Charlotte, Florida, 33980, United States

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Status: Recruiting

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Sarasota, Florida, 34236, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Stuart, Florida, 34994, United States

No email / No phone

Status: Active, not recruiting

Florida Cancer Specialists

Tallahassee, Florida, 32308, United States

No email / No phone

Status: Recruiting

Moffitt Cancer Center McKinley Hospital

Tampa, Florida, 33612, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Venice, Florida, 34285, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Venice, Florida, 34292, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists

Vero Beach, Florida, 32960, United States

No email / No phone

Status: Active, not recruiting

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

No email / No phone

Status: Active, not recruiting

Florida Cancer Specialists

Wellington, Florida, 33414, United States

No email / No phone

Status: Active, not recruiting

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Marietta, Georgia, 30060, United States

No email / No phone

Status: Recruiting

Northwest Georgia Oncology Centers, a Service of Tanner Medical Center Villa Rica

Carrollton, Georgia, 30117, United States

No email / No phone

Status: Recruiting

West Georgia Infusion Center, a Service of Tanner Medical Center Villa Rica

Carrollton, Georgia, 30117, United States

No email / No phone

Status: Recruiting

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Cartersville, Georgia, 30121, United States

No email / No phone

Status: Recruiting

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Douglasville, Georgia, 30134, United States

No email / No phone

Status: Recruiting

Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital

Hiram, Georgia, 30141, United States

No email / No phone

Status: Recruiting

WellStar Paulding Hospital

Hiram, Georgia, 30141, United States

No email / No phone

Status: Recruiting

Northwest Georgia Oncology Centers

Marietta, Georgia, 30060, United States

No email / No phone

Status: Recruiting

The University of Chicago Medicine Center for Advanced Care Orland Park

Orland Park, Illinois, 60462, United States

No email / No phone

Status: Recruiting

UChicago Medicine - River East

Chicago, Illinois, 60611, United States

No email / No phone

Status: Recruiting

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

No email / No phone

Status: Recruiting

Accellacare - Deerfield

Deerfield, Illinois, 60015, United States

No email / No phone

Status: Recruiting

UChicago Medicine at Ingalls - Flossmoor

Flossmoor, Illinois, 60422, United States

No email / No phone

Status: Recruiting

UChicago Medicine Ingalls Memorial

Harvey, Illinois, 60426, United States

No email / No phone

Status: Recruiting

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

New Lenox, Illinois, 60451, United States

No email / No phone

Status: Recruiting

UChicago Medicine at Ingalls - Tinley Park

Tinley Park, Illinois, 60477, United States

No email / No phone

Status: Recruiting

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

No email / No phone

Status: Recruiting

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

No email / No phone

Status: Recruiting

Cancer & Hematology Centers of Western Michigan, PC

Holland, Michigan, 49424, United States

No email / No phone

Status: Recruiting

Cancer & Hematology Centers of Western Michigan, PC

Norton Shores, Michigan, 49444, United States

No email / No phone

Status: Recruiting

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States

No email / No phone

Status: Recruiting

Cancer & Hematology Centers of Western Michigan, PC- Kit Storage

Grand Rapids, Michigan, 49546, United States

No email / No phone

Status: Recruiting

Cancer & Hematology Centers of Western Michigan, PC

Grand Rapids, Michigan, 49503, United States

No email / No phone

Status: Recruiting

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

No email / No phone

Status: Recruiting

Henry Ford Hospital

Detroit, Michigan, 48202, United States

No email / No phone

Status: Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

No email / No phone

Status: Recruiting

MSK Bergen

Montvale, New Jersey, 07645, United States

No email / No phone

Status: Recruiting

MSK Basking Ridge

Basking Ridge, New Jersey, 07920, United States

No email / No phone

Status: Recruiting

MSK Monmouth

Middletown, New Jersey, 07748, United States

No email / No phone

Status: Recruiting

Memorial Sloan Kattering Cancer Centre- Investigational Drug Service Pharmacy

Long Island City, New York, 11101, United States

No email / No phone

Status: Recruiting

Ship study drug to: Mount Sinai Hospital- Pharmacy Dept

New York, New York, 10029, United States

No email / No phone

Status: Recruiting

Evelyn H. Lauder Breast and Imaging Centre (BAIC)

New York, New York, 10065, United States

No email / No phone

Status: Recruiting

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065, United States

No email / No phone

Status: Recruiting

Sidney Kimmel Centre for Prostate and Urological Cancer

New York, New York, 10065, United States

No email / No phone

Status: Recruiting

MSK nassau

Uniondale, New York, 11553, United States

No email / No phone

Status: Recruiting

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

No email / No phone

Status: Active, not recruiting

MSK Wesrchester

Harrison, New York, 10604, United States

No email / No phone

Status: Recruiting

Northwell Health

Lake Success, New York, 11042, United States

No email / No phone

Status: Recruiting

Carolinas Medical Center Investigational Drug Services

Charlotte, North Carolina, 28204, United States

No email / No phone

Status: Recruiting

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Chapel Hill, North Carolina, 27599, United States

No email / No phone

Status: Not yet recruiting

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

No email / No phone

Status: Not yet recruiting

Atrium Health Union (biopsy only)

Monroe, North Carolina, 28112, United States

No email / No phone

Status: Recruiting

Levine Cancer Institute Concord

Concord, North Carolina, 28025, United States

No email / No phone

Status: Recruiting

Atrium Health Cabarrus (biopsy only)

Concord, North Carolina, 28025, United States

No email / No phone

Status: Recruiting

Levine Cancer Institute - Ballantyne

Charlotte, North Carolina, 28277, United States

No email / No phone

Status: Recruiting

Levine Cancer Institute University

Charlotte, North Carolina, 28262, United States

No email / No phone

Status: Recruiting

Atrium Health University City (biopsy only)

Charlotte, North Carolina, 28262, United States

No email / No phone

Status: Recruiting

Atrium Health Pineville (biopsy only)

Charlotte, North Carolina, 28210, United States

No email / No phone

Status: Recruiting

Atrium Health Mercy (biopsy only)

Charlotte, North Carolina, 28207, United States

No email / No phone

Status: Recruiting

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

No email / No phone

Status: Recruiting

Carolinas Medical Center (biopsy only)

Charlotte, North Carolina, 28203, United States

No email / No phone

Status: Recruiting

Ohio State University

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

Ohio State University Hospital

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

James Cancer Hospital & Solove Research Institute

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

No email / No phone

Status: Recruiting

OSU Wexner Medical Center & James Cancer Hospital

Columbus, Ohio, 43210, United States

No email / No phone

Status: Not yet recruiting

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

No email / No phone

Status: Recruiting

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

No email / No phone

Status: Recruiting

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

No email / No phone

Status: Recruiting

Baylor Scott and White Research Institute

Dallas, Texas, 75204, United States

No email / No phone

Status: Not yet recruiting

Baylor Scott & White Medical Center - Temple

Temple, Texas, 76508, United States

No email / No phone

Status: Not yet recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

No email / No phone

Status: Recruiting

Huntsman Cancer Institute at The University of Utah

Salt Lake City, Utah, 84112, United States

No email / No phone

Status: Not yet recruiting

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

No email / No phone

Status: Recruiting

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

No email / No phone

Status: Recruiting

Harborview Medical Center

Seattle, Washington, 98104, United States

No email / No phone

Status: Recruiting

University of Washington Medical Center

Seattle, Washington, 98195, United States

No email / No phone

Status: Recruiting

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

No email / No phone

Status: Recruiting

A Phase 2 Multi-Cohort, Open-Label, Multi-Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48-ADC) Alone or in Combination With Pembrolizumab in Subjects With Locally-Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2

Trial Details

Show Summary from Sponsor

Investigational Drug AI Analysis

Show for: disitamab vedotin (RC48, Aidixi)

Clinical Efficacy and Safety

Sources:

HealthScout AI Analysis

Eligibility

Show Criteria

Sites (178)

Clinica Viedma

Instituto Medico Especializado Alexander Fleming

Hospital Aleman

Hospital Sirio Libanes - Buenos Aires

Instituto Oncologico de Cordoba

Centro Oncologico Korben

Centro Medico Austral

Fundacion Cenit

GenesisCare - North Shore

Macquarie University

Mater Cancer Care Centre, Mater Misericordiae Limited

Peninsula & South Eastern Haematology and Oncology Group

Princess Alexandra Hospital

Lyell McEwin Hospital

CHU UCL Namur-Site de Saint Elisabeth

AZ Maria Middelares

Arthur J.E. Child Comprehensive Cancer Centre

BC Cancer - Vancouver

BC Cancer - Vancouver Fairmont Medical Building

CancerCare Manitoba

Jewish General Hospital

Centre Hospitalier Universitaire de Sherbrooke

Pontificia Universidad Catolica de Chile

Oncovida SA

IC La Serena Research SpA

The Chaim Sheba Medical Center

Sheba Medical Center

Rabin medical Center

Rambam Health Care Campus

Tel Aviv Sourasky Medical Center

Ospedale San Raffaele

Centro di Riferimento Oncologico Di Aviano

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

S.C. Farmacia Interna

Azienda Ospedaliera S. Maria di Terni

Azienda Ospedaliero Universitaria Pisana

IOV-Istituto Oncologico Veneto IRCCS-U.O. Oncologia Medica 1-SC Farmacia

IRCCS Ospedale San Raffaele, U.O. Farmacia Studi Clinici

National Cancer Center Hospital East

Sapporo Medical University Hospital

Osaka University Hospital

Tokushima University Hospital

The Cancer Institute Hospital of JFCR

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Hospital Universitari Parc Tauli Sabadell

Hospital Universitario Virgen del Rocío

MD Anderson Cancer Center Madrid

MD Anderson Cancer Center - Madrid

Hospital Universitari Vall d'Hebrón

Beatson West of Scotland Cancer Centre

The Christie NHS Foundation Trust

The Christie NHS Foundation Trust - Christie Hospital

The Clatterbridge Cancer Centre NHS Foundation Trust, The Clatterbridge Cancer Centre - Wirral

Charing Cross Hospital

Barts Health NHS Trust, St Bartholomew's Hospital

Cambridge University Hospitals NHS Foundation Trust

Guy's Hospital

Banner MD Anderson Cancer Center

Banner Gateway Medical Center

UCSF Cancer Center MZ Phlebotomy

Kaiser Permanente Anaheim Kraemer Medical Offices

Kaiser Permanente Baldwin Park Medical Center

Kaiser Permanente Bellflower Medical Offices

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Kaiser Permanente Fontana Medical Center

Kaiser Permanente South Bay Medical center

Chao Family Comprehensive Cancer Center and Ambulatory Care

Kaiser Permanente Alton/Sand Canyon Medical Offices