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NCT04083599

PHASE1/PHASE2

GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors

Sponsor: Genmab

View on ClinicalTrials.gov

Summary

The goal of this trial is to learn about the antibody GEN1042 when it is used alone and when it is used together with another antibody cancer drug, pembrolizumab (with or without chemotherapy), for treatment of participants with certain types of cancer.

Official title: A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2019-09-17

Completion Date

2026-11

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Malignant Solid Tumor Non-Small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Melanoma Head and Neck Squamous Cell Carcinoma (HNSCC)Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

BIOLOGICAL

GEN1042

Intravenous

DRUG

Pembrolizumab

Intravenous

DRUG

Cisplatin

Intravenous

DRUG

Carboplatin

Intravenous

DRUG

5-FU

Intravenous

DRUG

Gemcitabine

Intravenous

DRUG

Nab paclitaxel

Intravenous

DRUG

Pemetrexed

Intravenous

DRUG

Paclitaxel

Intravenous

Key Inclusion Criteria: Monotherapy - Dose Escalation and Dose Expansion Parts * Participants with non-CNS solid tumors that is metastatic or unresectable and for whom there is no available standard therapy. * Participants with a confirmed diagnosis of relapsed or refractory, advanced and/or metastatic melanoma, NSCLC, or CRC and for whom there is no available standard therapy Combination Therapy - Dose Expansion Part * Participants with unresectable Stage III or Stage IV melanoma with no prior systemic anticancer therapy for unresectable or metastatic disease. Primary ocular or mucosal melanoma is excluded. * Participants with Stage IV metastatic or recurrent NSCLC with no prior systemic anticancer therapy, no actionable mutation. * Participants with recurrent or metastatic HNSCC with no prior systemic therapy administered in the recurrent or metastatic setting. * Participants with confirmed metastatic PDAC with no previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease. General (all phases): * Must be age ≥ 18 years of age on the day of signing informed consent, or the legal age of consent in the jurisdiction in which the trial is taking place. * Measurable disease according to RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) 0-1 * Normal or adequate liver, renal, cardiac and bone marrow function Key Exclusion Criteria: Monotherapy - Dose Escalation and Dose Expansion Parts * Treatment with an anti-cancer agent (within 21 days or after at least 5 half-lives of the drug, whichever is shorter), prior to GEN1042 administration * Radiotherapy within 14 days prior to first GEN1042 administration * Toxicities from previous anti-cancer therapies that have not resolved Combination Therapy - Dose Expansion Part * Has received prior systemic cytotoxic chemotherapy, biological therapy, OR major surgery within 3 weeks or at least 5 half-lives of the drug (whichever is shorter) of the first dose of trial treatment. * Radiotherapy within 14 days of start of trial treatment or received lung radiation therapy of \> 30 Gy within 6 months of the first dose of trial treatment. General (all phases) * Participants has an active, known, or suspected autoimmune disease. * History of non-infectious pneumonitis that required steroids or currently has pneumonitis. * History of ≥ grade 3 allergic reactions to monoclonal antibody (mAb) therapy * Participants with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (76)

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Cancer & Blood Specialty Clinic

Los Alamitos, California, United States

Moores Cancer Center at the UC San Diego Health

San Diego, California, United States

Yale University Cancer Center

New Haven, Connecticut, United States

ChristianaCare

Newark, Delaware, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

Florida Cancer Affiliates

Ocala, Florida, United States

Hope and Healing Cancer Services

Hinsdale, Illinois, United States

University of Kentucky

Lexington, Kentucky, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Maryland Oncology Hematology PA

Columbia, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Levine Cancer Center

Charlotte, North Carolina, United States

Novant Health Cancer Institute - Forsyth (Medical Oncology)

Winston-Salem, North Carolina, United States

Kaiser Permanente (KP) Oncology/Hematology

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Lumi Research

Kingwood, Texas, United States

Utah Cancer Specialists

Salt Lake City, Utah, United States

Virgina Cancer Specialists

Fairfax, Virginia, United States

Adventist Health System/Sunbelt,Inc

Seattle, Washington, United States

Medical Oncology Associates, PS

Spokane, Washington, United States

Rigshospitalet (Copenhagen University Hospital)

Copenhagen, Denmark

Herlev University Hospital

Herlev, Denmark

University Hospital of Southern Denmark, Vejle Hospital

Vejle, Denmark

Centre hospitalier Universitaire de Bordeaux

Bordeaux, France

Centre Antoine Lacassagne

Nice, France

Gustave Roussy

Villejuif, France

ARENSIA Research Clinic at the Research Institute of Clinical Medicine

Tbilisi, Georgia

Nationales Centrum fr Tumorerkrankungen NCT

Heidelberg, Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany

Department of Dermatology, University of Mainz

Mainz, Germany

UniversitÃ¤tsmedizin Mannheim Dermatologie

Mannheim, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Rabin Medical Center

Petah Tikva, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Azienda Ospedaliera S.Croce e Carle Cuneo

Cuneo, Italy

Istituto Nazionale dei Tumori

Milan, Italy

Istituto Clinico Humanitas

Rozzano, Italy

ARENSIA Research Clinic at the Oncology Institute

Chisinau, Moldova

Chungbuk National University Hospital

Cheongju-si, South Korea

Jeonbuk National University Hospital

Jeonju, South Korea

Gachon University Gil Medical Center

Namdong, South Korea

Korea University Guro Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

H. Vall d'Hebron

Barcelona, Spain

START Barcelona HM Nou Delfos

Barcelona, Spain

Hospital Duran i Reynals - ICO L Hospitalet

L'Hospitalet de Llobregat, Spain

Hospital Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Spain

Hospital Universitario Lucus Augusti

Lugo, Spain

Clinica Universidad de Navarra

Madrid, Spain

HM CIOCC Hospital Universitario HM Sanchinarro

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital General Universitario Gregorio Maran

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

MD Anderson Cancer Center Madrid

Madrid, Spain

START Madrid - Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, Spain

Hospital Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch

Kaohsiung City, Taiwan

Kaohsiung Medical University Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital, VGHTPE

Taipei, Taiwan

Chang Gung Memorial Hospital Linkou Branch

Taoyuan District, Taiwan

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Clinical Research Directory

GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (76)