A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination With Other Anticancer Therapies in Solid Tumors

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Investigational drug late phase More information Active drug More information High burden on patient More information

Trial Details

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

Phase: 2

Start date: May 20, 2024

Planned enrollment: 172

Trial ID: NCT06157892
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More trial details at ClinicalTrials.gov More info

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chevron Show for: disitamab vedotin (RC48, Aidixi)

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Goal: The trial aims to assess the safety, tolerability, and preliminary efficacy of disitamab vedotin in combination with tucatinib in patients with locally advanced or metastatic HER2-expressing breast cancer or gastric/gastroesophageal junction adenocarcinoma. The study will determine optimal dosing and evaluate the benefit/risk profile of this combination across HER2-low and HER2-positive disease settings.

Patients: Eligible patients have locally advanced or metastatic breast cancer or gastric/gastroesophageal junction adenocarcinoma with measurable disease and HER2 expression (either HER2-low or HER2-positive), ECOG 0-1, and must have received and progressed on or been intolerant to standard therapies. Four main cohorts will be studied based on cancer type (breast or gastric/GEJC) and HER2 status (low or positive).

Design: The trial uses an open-label, randomized, multi-phase design. Initial dose escalation and optimization phases inform combination tolerability and identify appropriate dosing, followed by a dose expansion phase with four specific HER2-low and HER2+ patient cohorts. Approximately 172 patients will be enrolled.

Treatments: All patients receive the combination of disitamab vedotin and tucatinib. Disitamab vedotin is an antibody-drug conjugate targeting HER2, composed of a humanized anti-HER2 monoclonal antibody linked to the cytotoxic agent MMAE. In clinical trials, it has demonstrated promising ORR and PFS in both HER2-high and HER2-low metastatic breast cancer and is approved in China for metastatic gastric cancer after chemotherapy. Common adverse events include elevated liver enzymes, neuropathy, asthenia, and neutropenia, with grade 3+ AEs manageable in most patients. Tucatinib is an approved small molecule HER2 tyrosine kinase inhibitor marketed as TUKYSA and is included in the regimen for its efficacy in HER2-positive disease.

Outcomes: Primary endpoints include safety measures (rates of laboratory abnormalities, dose-limiting toxicities, adverse events, and dose modifications) and efficacy (objective response rate per RECIST v1.1). Secondary endpoints include duration of response, disease control rate, progression-free survival, overall survival, pharmacokinetics, and immunogenicity (ADA incidence).

Burden on patient: The patient burden is moderate to high, particularly in the dose escalation phase. Participants will undergo frequent clinic visits for safety assessments, adverse event monitoring, laboratory testing, pharmacokinetic blood draws, and imaging for disease assessment. Additional tumor biopsies may be required for HER2 status confirmation, and patients with gastric/GEJ cancer must provide archival or repeat tumor tissue. Such intensive monitoring and testing exceed standard of care and are typical for early phase combination studies.

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Slade Health

Mount Waverley, Victoria, 3149, Australia

No email / No phone

Status: Not yet recruiting

Slade Pharmacy Frankston

Frankston, Victoria, 3199, Australia

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Status: Not yet recruiting

Peninsula & South Eastern Hematology and Oncology Group (PASO)

Frankston, Victoria, 3199, Australia

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Peninsula & South Eastern Hematology and Oncology Group (PASO)

Frankston, Australia

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BC Cancer Kelowna.

Kelowna, British Columbia, V1Y5L3, Canada

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Status: Recruiting

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

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Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

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Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

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Universitatsklinikum Essen

Essen, 45147, Germany

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Universitatsklinikum Heidelberg

Heidelberg, 69120, Germany

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Klinikums rechts der Isar der TU München

Muenchen, 81675, Germany

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A.O.U. Federico II

Napoli, Campania, 80131, Italy

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Azienda Ospedaliera Universitaria (AOU) Federico II

Napoli, Campania, 80131, Italy

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Istituto Nazionale Tumori IRCCS Fondazione G. Pascale.

Napoli, Campania, 80131, Italy

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Istituto Europeo di Oncologia

Milano, Lombardia, 20141, Italy

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Niguarda Ca' Granda Hospital

Milano, Lombardia, 20162, Italy

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Humanitas Istituto Clinico Catanese

Misterbianco (CT), Sicilia, 95045, Italy

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Azienda Ospedaliera Universitaria Integrata di Verona.

Verona, Veneto, 37134, Italy

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A.O.U. Federico II- U.O.C. Diagnostica per lmmagini e Radioterapia

Napoli, 80131, Italy

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Dong-A University Hospital

Busan, Other, 49201, Korea, Republic of

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National Cancer Center

Goyang-si, Other, 10408, Korea, Republic of

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Chungbuk National University Hospital

Cheongju-si, 28644, Korea, Republic of

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Gachon University Gil Medical Center

Incheon, 21565, Korea, Republic of

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Seoul National University Bundang Hospital

Seongnam-si, 463-707, Korea, Republic of

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Korea University Anam Hospital

Seoul, 02841, Korea, Republic of

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Samsung Medical Center

Seoul, 06351, Korea, Republic of

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Seoul National University Hospital

Seoul, 110-744, Korea, Republic of

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Severance Hospital Yonsei University Health System

Seoul, 3722, Korea, Republic of

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St. Vincent's Hospital, The Catholic University of Korea

Suwon-si, 16247, Korea, Republic of

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Quirén Salud Barcelona

Barcelona, 08023, Spain

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Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

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Ecg Medica Sl

Valencia, 46004, Spain

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START Madrid-CIOCC_Hospital HM Sanchinarro

Madrid, 28050, Spain

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Farmacia-Ensayos. Planta S - Hospital Universitario HM Sanchinarro-CIOCC-START Madrid

Madrid, 28050, Spain

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Status: Recruiting

L'Institut Catala d'Oncologia.

L'Hospitalet de Llobregat, 08908, Spain

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Grupo Hospitalario QuironSalud

Erandio Bizkaia, 48950, Spain

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Hospital Universitario de Basurto

Bilbao, 48013, Spain

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CETIR Grup Medic

Barcelona, 08950, Spain

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Hospital Universitari Vall d´Hebron

Barcelona, 08035, Spain

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National Cheng Kung University Hospital

Tainan, 704, Taiwan

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National Taiwan University Hospital

Taipei, 100225, Taiwan

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National Taiwan University Hospital

Taipei, 100, Taiwan

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National Taiwan University Cancer Center

Taipei, 106, Taiwan

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National Cheng Kung University Hospital

Tainan, 704017, Taiwan

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The Royal Marsden Hospital

Sutton, Surrey, SM2 5PT, United Kingdom

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Status: Recruiting

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

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St Bartholomew's Hospital

London, EC1M 6BQ, United Kingdom

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The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

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Status: Recruiting

The Royal Marsden NHS Foundation Trust (RM)

London, SW3 6JJ, United Kingdom

No email / No phone

Status: Recruiting

The Christie NHS Foundation Trust

Manchester, M20 4GJ, United Kingdom

No email / No phone

Status: Not yet recruiting

The University of Arizona Cancer Center-Main

Tucson, Arizona, 85724, United States

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Status: Recruiting

University of Arizona Cancer Center - North Campus

Tucson, Arizona, 85719, United States

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Status: Recruiting

The University of Arizona Cancer Center-North Campus Pharmacy, Attn: Kelly Myrdal

Tucson, Arizona, 85719, United States

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Status: Recruiting

Banner-University Medical Center Tucson

Tucson, Arizona, 85719, United States

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Status: Recruiting

Banner-University Medical Center Tucson Campus

Tucson, Arizona, 85719, United States

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Banner-University Medical Center Tucson Campus

Tucson, Arizona, 85704, United States

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UCLA Department of Medicine - Hematology & Oncology

Santa Monica, California, 90504, United States

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UC Irvine Medical Center

Orange, California, 92868, United States

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Status: Recruiting

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

San Francisco, California, 94158, United States

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Colorado West Healthcare, dba Grand Valley Oncology

Grand Junction, Colorado, 81505, United States

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Status: Recruiting

Colorado West Healthcare System, dba Community Hospital

Grand Junction, Colorado, 81505, United States

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Status: Recruiting

Danbury Hospital

Danbury, Connecticut, 06810, United States

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Status: Recruiting

The Whittingham Cancer Center / Norwalk Hospital

Norwalk, Connecticut, 06856, United States

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Status: Recruiting

Georgetown University Medical Center

Washington, District of Columbia, 20007, United States

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Status: Recruiting

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007, United States

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Status: Recruiting

Moffitt Cancer Center - International Plaza

Tampa, Florida, 33607, United States

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Status: Recruiting

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

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Status: Recruiting

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612, United States

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Status: Recruiting

Moffitt McKinley Hospital

Tampa, Florida, 33612, United States

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Status: Recruiting

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, 33544, United States

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Status: Recruiting

Georgia Cancer Specialists - Marietta

Marietta, Georgia, 30060, United States

No email / No phone

Status: Recruiting

Georgia Cancer Specialists - Athens

Athens, Georgia, 30606, United States

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Status: Recruiting

Georgia Cancer Specialists - Annex

Atlanta, Georgia, 30341, United States

No email / No phone

Status: Recruiting

Atlanta Cancer Care - Atlanta

Atlanta, Georgia, 30342, United States

No email / No phone

Status: Recruiting

Georgia Cancer Specialists-Northside

Atlanta, Georgia, 30342, United States

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Status: Recruiting

Northside Hospital, Inc.- Central Research Department

Atlanta, Georgia, 30342, United States

No email / No phone

Status: Recruiting

Northside Hospital

Atlanta, Georgia, 30342, United States

No email / No phone

Status: Recruiting

Georgia Cancer Specialists - Blairsville

Blairsville, Georgia, 30512, United States

No email / No phone

Status: Recruiting

Georgia Cancer Specialists - Canton

Canton, Georgia, 30115, United States

No email / No phone

Status: Recruiting

Atlanta Cancer Care - Cumming

Cumming, Georgia, 30041, United States

No email / No phone

Status: Recruiting

Georgia Cancer Specialists - Cumming

Cumming, Georgia, 30041, United States

No email / No phone

Status: Recruiting

Georgia Cancer Specialists - Decatur

Decatur, Georgia, 30033, United States

No email / No phone

Status: Recruiting

Suburban Hematology-Oncology Associates - Duluth

Duluth, Georgia, 30096, United States

No email / No phone

Status: Recruiting

Suburban Hematology-Oncology Associates- Lawrenceville

Lawrenceville, Georgia, 30046, United States

No email / No phone

Status: Recruiting

Georgia Cancer Specialists - Macon

Macon, Georgia, 31217, United States

No email / No phone

Status: Recruiting

Memorial Hospital

Shiloh, Illinois, 62269, United States

No email / No phone

Status: Recruiting

Siteman Cancer Center - Shiloh

Shiloh, Illinois, 62269, United States

No email / No phone

Status: Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Recruiting

Massachusetts General Hospital.

Boston, Massachusetts, 02114, United States

No email / No phone

Status: Recruiting

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Recruiting

Dana Farber Cancer Institute- Chestnut Hill

Newton, Massachusetts, 02459, United States

No email / No phone

Status: Recruiting

Barnes-Jewish Hospital

Saint Louis, Missouri, 63110, United States

No email / No phone

Status: Recruiting

Siteman Cancer Center - St Peters

Saint Peters, Missouri, 63376, United States

No email / No phone

Status: Recruiting

Siteman Cancer Center - South County

Saint Louis, Missouri, 63129, United States

No email / No phone

Status: Recruiting

Washington University School of Medicine - Siteman Cancer Center

Saint Louis, Missouri, 63110, United States

No email / No phone

Status: Recruiting

Washington University in St Louis.

Saint Louis, Missouri, 63110, United States

No email / No phone

Status: Recruiting

St Lukes Hospital

Kansas City, Missouri, 64111, United States

No email / No phone

Status: Recruiting

Saint Luke's Hospital Investigational Pharmacy

Kansas City, Missouri, 64111, United States

No email / No phone

Status: Recruiting

Saint Luke's Cancer Institute LLC

Kansas City, Missouri, 64111, United States

No email / No phone

Status: Recruiting

Siteman Cancer Center - North County

Florissant, Missouri, 63031, United States

No email / No phone

Status: Recruiting

Siteman Cancer Center - West County

Creve Coeur, Missouri, 63141, United States

No email / No phone

Status: Recruiting

Renown Regional Medical Center

Reno, Nevada, 89502, United States

No email / No phone

Status: Recruiting

San Juan Oncology Associates

Farmington, New Mexico, 87401, United States

No email / No phone

Status: TERMINATED

Memorial Sloan Kettering Cancer Center - Main Hospital

New York, New York, 10065, United States

No email / No phone

Status: Recruiting

Zangmeister Cancer Center

Columbus, Ohio, 43219, United States

No email / No phone

Status: Recruiting

Saint Francis Hospital / Bon Secours - South Carolina

Greenville, South Carolina, 29607, United States

No email / No phone

Status: Recruiting

Tennessee Oncology-Nashville/Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

Sarah Cannon Research Institute - Pharmacy

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

No email / No phone

Status: Recruiting

University of Texas Southwestern Medical Center Simmons Cancer Center - Richardson/Plano

Richardson, Texas, 75080, United States

No email / No phone

Status: Recruiting

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

No email / No phone

Status: Recruiting

University of Texas Southwestern Medical Center - Simmons Cancer Center

Dallas, Texas, 75235, United States

No email / No phone

Status: Recruiting

University of Texas Southwestern Medical Center-Simmons Cancer Center Pharmacy

Dallas, Texas, 75235, United States

No email / No phone

Status: Recruiting

University of Texas Southwestern Medical Center Simmons Cancer Center - Redbird

Dallas, Texas, 75237, United States

No email / No phone

Status: Recruiting

University of Texas Southwestern Medical Center Clinical Lab-Zale Lipshy University Hospital

Dallas, Texas, 75390, United States

No email / No phone

Status: Recruiting

University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital

Dallas, Texas, 75390, United States

No email / No phone

Status: Recruiting

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

No email / No phone

Status: Recruiting

University of Texas Southwestern Simmons Cancer Center - Fort Worth

Fort Worth, Texas, 76104, 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

Fred Hutchinson Cancer Center / Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98109, United States

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Status: Recruiting

Carbone Cancer Center / University of Wisconsin

Madison, Wisconsin, 53792, United States

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Status: Recruiting

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718, United States

No email / No phone

Status: Recruiting

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