RecruitingPhase 2NCT06172478

A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors

HERTHENA-PanTumor01 (U31402-277): A Phase 2, Multicenter, Multicohort, Open-Label, Proof of Concept Study of Patritumab Deruxtecan (HER3-DXd; U3-1402) in Subjects With Locally Advanced or Metastatic Solid Tumors

Sponsor

Daiichi Sankyo

Enrollment

740 participants

Start Date

Feb 26, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Esophageal Cancer Gastric Cancer Non-small Cell Lung Cancer (NSCLC)Cervical Cancer Endometrial Cancer Prostate Cancer Ovarian Carcinoma Pancreatic Carcinoma Lung Cancer Melanoma Head and Neck Cancer Advanced Solid Tumor Bladder Cancer

Summary

This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \[cutaneous/acral\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a targeted antibody drug called HER3-DXd in people with advanced or metastatic solid tumors — including melanoma, bladder cancer, colorectal cancer, ovarian cancer, and head/neck cancers — that have stopped responding to previous treatments. **You may be eligible if...** - You are 18 or older with advanced cancer that cannot be removed by surgery or cured by radiation - Your cancer has progressed after at least one prior line of treatment (such as immunotherapy or chemotherapy) - You have one of the eligible cancer types: melanoma, bladder cancer, colorectal cancer, certain gynecological cancers, or head and neck cancers - You have adequate organ function **You may NOT be eligible if...** - You have not yet tried other standard treatments for your cancer - Your cancer does not match one of the specific tumor types listed in the study - You have active, untreated brain metastases - You have certain heart, lung, or liver conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHER3-DXd

Intravenous infusion 5.6 mg/kg administered Q3W on Day 1 of each 21-day cycle

Locations(84)

City of Hope

Duarte, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

AdventHealth Medical Group Oncology Research at Celebration

Kissimmee, Florida, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Johns Hopkins University

Baltimore, Maryland, United States

Health Partners Frauenshuh Cancer Center

Saint Louis Park, Minnesota, United States

Health Partners Cancer Center at Regions Hospital

Saint Paul, Minnesota, United States

Washington University, School of Medicine

St Louis, Missouri, United States

Roswell Park Cancer Institute IDS

Buffalo, New York, United States

Memorial Sloan Kettering Hospital

New York, New York, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Chris O'Brien Lifehouse

Camperdown, Australia

Icon Cancer Centre Chermside

Chermside, Australia

Monash Medical Centre Clayton

Clayton, Australia

Icon Cancer Centre Hobart

Hobart, Australia

Icon Cancer Centre Townsville

Hyde Park, Australia

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZA

Edegem, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitair Ziekenhuis Brussel

Jette, Belgium

UZ Leuven

Leuven, Belgium

Cross Cancer Institute

Edmonton, Alberta, Canada

Sunnybrook Research Institute

Toronto, Canada

Princess Margaret Cancer Centre

Toronto, Canada

BC Cancer - Vancouver

Vancouver, Canada

Sun Yat-sen University Cancer Center

Guangzhou, China

Chu Bordeaux

Bordeaux, France

Centre Georges Franăois Leclerc

Dijon, France

Hopital Claude Huriez - Chu Lille

Lille, France

Centre Léon Bérard

Lyon, France

Hăpital de La Timone

Marseille, France

Chu Nantes - Hătel Dieu

Nantes, France

Institut Claudius Regaud

Toulouse, France

ICL - Alexis Vautrin

Vandœuvre-lès-Nancy, France

Institut Gustave Roussy

Villejuif, France

Krankenhaus Nordwest GmbH

Frankfurt, Germany

Bacs-Kiskun Varmegyei Oktatokorhaz

Kecskemét, Hungary

Humanitas Gavazzeni

Bergamo, Italy

IRCCS Ospedale Policlinico San Martino

Genova, Italy

AOU Federico II - Oncologia Clinica

Naples, Italy

Centro Ricerche Cliniche di Verona s.r.l.

Verona, Italy

Saitama Medical University International Medical Center

Hidaka, Japan

National Cancer Center Hospital East

Kashiwa-shi, Japan

NHO Shikoku Cancer Center

Matsuyama, Japan

Shizuoka Cancer Center

Nagaizumi-cho, Japan

Aichi Cancer Center Hospital

Nagoya, Japan

Kindai University Hospital

Osakasayama-shi, Japan

National Cancer Center Hospital

Tokyo, Japan

Cancer Institute Hospital of JFCR

Tokyo, Japan

Yokohama City University Medical Center

Yokohama, Japan

Amsterdam UMC locatie Vumc

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Leids Universitair Medisch Centrum

Leiden, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Radboud University Medical Center

Nijmegen, Netherlands

Akershus universitetssykehus

Lørenskog, Norway

Haukeland universitetssjukehus

Lørenskog, Norway

Oslo Universitetssykehus HF, Radiumhospitalet

Oslo, Norway

Cha Bundang Medical Center, Cha University

Seongnam, South Korea

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

HOSPITAL REGIONAL UNIVERSITARIO de MALAGA AVDA.

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital

Taoyuan, Taiwan

University Hospital Coventry

Coventry, United Kingdom

Barts Hospital

London, United Kingdom

Royal Free Hospital

London, United Kingdom

Nottingham City Hospital Campus

Nottingham, United Kingdom

View Full Details on ClinicalTrials.gov

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