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New antibody combo tested against hard-to-treat cancers

NCT ID NCT04083599

Disease control Sponsor: Genmab Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 4 times

Summary

This early-phase trial tests an experimental antibody called GEN1042, given alone or with the cancer drug pembrolizumab (and sometimes chemotherapy), in people with advanced solid tumors like lung, colon, melanoma, head and neck, or pancreatic cancer. The main goals are to check safety and see if the drug shrinks tumors. About 350 adults whose cancer has not responded to standard treatments will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

350 people

The number who actually took part.

Started

Sep 2019

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cancer colorectal cancer colorectal neoplasm head and neck squamous cell carcinoma melanoma non-small cell lung carcinoma pancreatic ductal adenocarcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer (CRC) Head and neck squamous cell carcinoma HNSCC Malignant solid tumor Melanoma Non-small cell lung cancer (NSCLC) Pancreatic ductal adenocarcinoma (PDAC)

Contacts and locations

Locations

  • ARENSIA Research Clinic at the Oncology Institute

    Chisinau, Moldova

  • ARENSIA Research Clinic at the Research Institute of Clinical Medicine

    Tbilisi, Georgia

  • Adventist Health System/Sunbelt,Inc

    Seattle, Washington, 98109, United States

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508, United States

  • Azienda Ospedaliera S.Croce e Carle Cuneo

    Cuneo, Italy

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia, Italy

  • Cancer & Blood Specialty Clinic

    Los Alamitos, California, 90720, United States

  • Centre Antoine Lacassagne

    Nice, France

  • Centre hospitalier Universitaire de Bordeaux

    Bordeaux, France

  • Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch

    Kaohsiung City, Taiwan

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan, Taiwan

  • China Medical University Hospital

    Taichung, Taiwan

  • ChristianaCare

    Newark, Delaware, 19713, United States

  • Chungbuk National University Hospital

    Cheongju-si, South Korea

  • Clinica Universidad de Navarra

    Madrid, Spain

  • Clinica Universidad de Navarra

    Pamplona, Spain

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, Spain

  • Department of Dermatology, University of Mainz

    Mainz, Germany

  • Florida Cancer Affiliates

    Ocala, Florida, 34474, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Gachon University Gil Medical Center

    Namdong, South Korea

  • Gustave Roussy

    Villejuif, France

  • H. Vall d'Hebron

    Barcelona, Spain

  • HM CIOCC Hospital Universitario HM Sanchinarro

    Madrid, Spain

  • Herlev University Hospital

    Herlev, Denmark

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521, United States

  • Hospital Clinico San Carlos

    Madrid, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, Spain

  • Hospital Duran i Reynals - ICO L Hospitalet

    L'Hospitalet de Llobregat, Spain

  • Hospital General Universitario Gregorio Maran

    Madrid, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016, Spain

  • Hospital Universitario La Paz

    Madrid, Spain

  • Hospital Universitario Lucus Augusti

    Lugo, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Spain

  • Hospital Virgen del Rocio

    Seville, Spain

  • Istituto Clinico Humanitas

    Rozzano, Italy

  • Istituto Nazionale dei Tumori

    Milan, Italy

  • Jeonbuk National University Hospital

    Jeonju, South Korea

  • Kaiser Permanente (KP) Oncology/Hematology

    Portland, Oregon, 97227, United States

  • Kaohsiung Medical University Memorial Hospital

    Kaohsiung City, Taiwan

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, Germany

  • Korea University Guro Hospital

    Seoul, South Korea

  • Levine Cancer Center

    Charlotte, North Carolina, 28204, United States

  • Lumi Research

    Kingwood, Texas, 77339, United States

  • MD Anderson Cancer Center Madrid

    Madrid, Spain

  • Maryland Oncology Hematology PA

    Columbia, Maryland, 21044, United States

  • Medical Oncology Associates, PS

    Spokane, Washington, 99204, United States

  • Moores Cancer Center at the UC San Diego Health

    San Diego, California, 92037, United States

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140, United States

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • Nationales Centrum fr Tumorerkrankungen NCT

    Heidelberg, Germany

  • Norton Cancer Institute

    Louisville, Kentucky, 40202, United States

  • Novant Health Cancer Institute - Forsyth (Medical Oncology)

    Winston-Salem, North Carolina, 27103, United States

  • Pusan National University Yangsan Hospital

    Yangsan, South Korea

  • Rabin Medical Center

    Petah Tikva, Israel

  • Rigshospitalet (Copenhagen University Hospital)

    Copenhagen, Denmark

  • Royal Marsden NHS Foundation Trust

    Sutton, United Kingdom

  • START Barcelona HM Nou Delfos

    Barcelona, Spain

  • START Madrid - Hospital Universitario Fundacion Jimenez Diaz

    Madrid, Spain

  • Samsung Medical Center

    Seoul, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Taipei Medical University Hospital

    Taipei, Taiwan

  • Taipei Veterans General Hospital, VGHTPE

    Taipei, Taiwan

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israel

  • Universitaetsklinikum Wuerzburg

    Würzburg, Germany

  • University Hospital of Southern Denmark, Vejle Hospital

    Vejle, Denmark

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Universitätsmedizin Mannheim Dermatologie

    Mannheim, Germany

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84124, United States

  • Virgina Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale University Cancer Center

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.