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Active Not RecruitingPhase 1 / Phase 2NCT04083599
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGEN1042 and Pembrolizumab

Plus 7 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 4, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?76 U.S. locations

Locations may change over time.

Who runs it?Genmab

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Genmab
Interventions being studied
Biological: GEN1042; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: 5-FU; Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: Pemetrexed; Drug: Paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key 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
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Alaska Oncology and Hematology LLCAnchorage, Alaska
  • Cancer & Blood Specialty ClinicLos Alamitos, California
  • Moores Cancer Center at the UC San Diego HealthSan Diego, California
  • Yale University Cancer CenterNew Haven, Connecticut
  • ChristianaCareNewark, Delaware
  • Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
  • Florida Cancer AffiliatesOcala, Florida
  • Hope and Healing Cancer ServicesHinsdale, Illinois
  • University of KentuckyLexington, Kentucky
  • Norton Cancer InstituteLouisville, Kentucky
  • Maryland Oncology Hematology PAColumbia, Maryland
  • Washington University School of MedicineSt Louis, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 4, 2026. Always confirm current availability with the study team.

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