A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

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

Trial Details

Sponsor: Bayer (industry)

Phase: 2

Start date: Feb. 13, 2025

Planned enrollment: 111

Trial ID: NCT06760819
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More trial details at ClinicalTrials.gov More info

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Goal: To evaluate the efficacy and safety of the oral reversible tyrosine kinase inhibitor BAY2927088 in patients with metastatic or unresectable solid tumors harboring activating HER2 mutations, excluding NSCLC.

Patients: Adults with metastatic or unresectable, histologically or cytologically confirmed solid cancers (including colorectal, biliary tract, bladder, cervical, endometrial, and other solid tumors except NSCLC) with documented activating HER2 mutations who have previously received appropriate standard therapy or have no satisfactory alternative options. All participants must have at least one RECIST 1.1-measurable lesion.

Design: This is a non-randomized, open-label, phase 2 basket trial enrolling approximately 111 participants. All enrolled patients receive the investigational drug, with outcomes centrally assessed.

Treatments: All participants receive BAY2927088 at a dose of 20 mg orally twice daily until disease progression, unacceptable toxicity, or withdrawal. BAY2927088 is an oral, reversible tyrosine kinase inhibitor targeting mutant HER2 (ERBB2) and EGFR, designed to block abnormal HER2-driven signaling. In prior phase 1 and 2 studies in HER2-mutant NSCLC, BAY2927088 demonstrated promising efficacy, including an objective response rate of 70% and a manageable safety profile dominated by low-grade diarrhea and rash. The agent has received Breakthrough Therapy Designation for HER2-mutant NSCLC.

Outcomes: The primary outcome is objective response rate (ORR) per RECIST 1.1 assessed by blinded independent central review. Secondary outcomes include duration of response, time to response, disease control rate at various timepoints, progression-free survival, overall survival, safety and adverse event rates, and patient-reported quality of life measures using the EORTC QLQ-C30 instrument.

Burden on patient: The patient burden is expected to be moderate. Participants will require regular imaging studies (such as CT or MRI scans) for RECIST response assessment, routine blood and urine sampling, physical exams, cardiac monitoring (echocardiogram or cardiac MRI, ECG), and completion of quality-of-life questionnaires. The treatment is oral, avoiding the need for intravenous administration or frequent clinic visits for drug infusion, but the frequency of monitoring may be higher than standard care for advanced solid tumors. No additional invasive biopsies or intensive pharmacokinetic sampling are described, making the trial less burdensome compared to many early-phase studies.

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Sites (54)

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Blacktown Cancer & Haematology Centre

Blacktown, New South Wales, 2148, Australia

No email / No phone

Status: Recruiting

Macquarie University Hospital - Oncology Department

Sydney, New South Wales, 2109, Australia

No email / No phone

Status: Recruiting

ICON Cancer Centre - Southport

Southport, Queensland, 4215, Australia

No email / No phone

Status: Recruiting

Queen Elizabeth II Health Sciences Centre - Victoria General Site

Halifax, Nova Scotia, B3H 1V7, Canada

No email / No phone

Status: Recruiting

Princess Margaret Cancer Centre - University Health Network - Department of Medical Oncology and Hematology

Toronto, Ontario, M5G 2C4, Canada

No email / No phone

Status: Recruiting

McGill University Health Centre - Glen Site

Montreal, Quebec, H4A 3J1, Canada

No email / No phone

Status: Recruiting

Beijing Cancer Hospital - Oncology Department

Beijing, Beijing, 100142, China

No email / No phone

Status: Recruiting

Peking University First Hospital - Oncology Department

Beijing, Beijing, 100034, China

No email / No phone

Status: Recruiting

Hunan Cancer Hospital - Oncology Department

Changsha, Hunan, 410013, China

No email / No phone

Status: Recruiting

Zhongshan Hospital, Fudan University - Oncology Department

Shanghai, Shanghai, 200032, China

No email / No phone

Status: Recruiting

Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department

Hangzhou, Zhejiang, 310016, China

No email / No phone

Status: Recruiting

Fudan University Shanghai Cancer Center - Oncology Department

Shanghai, 200000, China

No email / No phone

Status: Recruiting

Aarhus University Hospital - Oncology Department

Aarhus N, 8200, Denmark

No email / No phone

Status: Recruiting

Rigshospitalet - Kræftbehandling

Copenhagen, 2100, Denmark

No email / No phone

Status: Recruiting

Odense University Hospital - Oncology Department

Odense C, 5000, Denmark

No email / No phone

Status: Recruiting

Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale

Bordeaux, 33000, France

No email / No phone

Status: Recruiting

CHU Brest - Hopital La Cavale Blanche - service oncologie medicale

Brest, 29200, France

No email / No phone

Status: Recruiting

Centre Oscar Lambret - Service Oncologie

Lille, 59000, France

No email / No phone

Status: Recruiting

Institut du Cancer Montpellier (ICM)

Montpellier, 34298, France

No email / No phone

Status: Not yet recruiting

Centre Hospitalier Lyon Sud - Service oncologie medicale

Pierre-Benite, 69310, France

No email / No phone

Status: Recruiting

Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)

Villejuif Cedex, 94805, France

No email / No phone

Status: Not yet recruiting

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

Roma, 00168, Italy

No email / No phone

Status: Recruiting

Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1

Milano, 20133, Italy

No email / No phone

Status: Recruiting

Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica

Milano, 20141, Italy

No email / No phone

Status: Not yet recruiting

Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale

Reggio Emilia, 42123, Italy

No email / No phone

Status: Recruiting

Aichi Cancer Center Hospital

Nagoya, Aichi, 464-8681, Japan

No email / No phone

Status: Recruiting

National Cancer Center Hospital East (NCCHE) - Kashiwa Campus

Kashiwa, Chiba, 277-8577, Japan

No email / No phone

Status: Recruiting

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

No email / No phone

Status: Recruiting

Kindai University Hospital

Osakasayama, Osaka, 589-8511, Japan

No email / No phone

Status: Recruiting

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

No email / No phone

Status: Recruiting

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

No email / No phone

Status: Recruiting

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 3080, Korea, Republic of

No email / No phone

Status: Recruiting

Asan Medical Center - Oncology Department

Seoul, Seoul Teugbyeolsi, 05505, Korea, Republic of

No email / No phone

Status: Recruiting

Severance Hospital, Yonsei University Health System - Oncology Department

Seoul, Seoul Teugbyeolsi, 03722, Korea, Republic of

No email / No phone

Status: Recruiting

Samsung Medical Center - Oncology Department

Seoul, 06351, Korea, Republic of

No email / No phone

Status: Recruiting

Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals - Oncology Department

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

No email / No phone

Status: Recruiting

Clinica Universidad de Navarra-Oncology Service

Madrid, Navarra, 28027, Spain

No email / No phone

Status: Recruiting

Hospital Quiron Dexeus - Oncologia

Barcelona, 08028, Spain

No email / No phone

Status: Not yet recruiting

Hospital Universitario Fundacion Jimenez Diaz- Oncology Service

Madrid, 28040, Spain

No email / No phone

Status: Recruiting

Hospital Universitari Vall d'Hebron- Oncology Service

Barcelona, 08035, Spain

No email / No phone

Status: Recruiting

Univestitätsspital Zürich (USZ)

Zürich, 8091, Switzerland

No email / No phone

Status: Recruiting

Hopitaux Universitaires de Geneve - Oncology Department

Genève, 1205, Switzerland

No email / No phone

Status: Recruiting

Inselspital Bern - Universitätsklinik für Medizinische Onkologie

Bern, 3010, Switzerland

No email / No phone

Status: Recruiting

UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital

Birmingham, Alabama, 35233, United States

No email / No phone

Status: Not yet recruiting

City of Hope - Duarte Cancer Center

Duarte, California, 91010, United States

No email / No phone

Status: Recruiting

Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus

Fort Myers, Florida, 33908, United States

No email / No phone

Status: Recruiting

Dana-Farber Cancer Institute - Oncology Department

Boston, Massachusetts, 02215, United States

No email / No phone

Status: Recruiting

Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit

Detroit, Michigan, 48202, United States

No email / No phone

Status: Withdrawn

Profound Research -OMG - TriAtria Cancer Center

Farmington Hills, Michigan, 48334, United States

No email / No phone

Status: Recruiting

Cleveland Clinic - Oncology Department

Cleveland, Ohio, 44195, 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 MD Anderson Cancer Center - Texas Medical Center

Houston, Texas, 77030-4000, United States

No email / No phone

Status: Recruiting

University of Washington Medical Center (UWMC) - Montlake - Gynecology Oncology

Seattle, Washington, 98195-0001, United States

No email / No phone

Status: Withdrawn

UW Health - UW Carbone Cancer Center - Medical Oncology Clinic

Madison, Wisconsin, 53792, United States

No email / No phone

Status: Recruiting

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