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Malignant Solid TumorPhase 1/2NCT04083599

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

A Phase 1/2 study testing GEN1042, Pembrolizumab and Cisplatin in people with Malignant Solid Tumor and Non-Small Cell Lung Cancer (NSCLC), run by Genmab at 76 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GEN1042, Pembrolizumab and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
76 sitesin 12 countries
Study dates
17 Sep 2019to Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

76 sites in 12 countries.

76 sites in 12 countries

United States23 sites

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Levine Cancer Center

    Charlotte, North Carolina, 28204

  • Maryland Oncology Hematology PA

    Columbia, Maryland, 21044

  • Virgina Cancer Specialists

    Fairfax, Virginia, 22031

  • Hope and Healing Cancer Services

    Hinsdale, Illinois, 60521

  • Lumi Research

    Kingwood, Texas, 77339

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Cancer & Blood Specialty Clinic

    Los Alamitos, California, 90720

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale University Cancer Center

    New Haven, Connecticut, 06520

  • ChristianaCare

    Newark, Delaware, 19713

  • Florida Cancer Affiliates

    Ocala, Florida, 34474

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Kaiser Permanente (KP) Oncology/Hematology

    Portland, Oregon, 97227

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84124

  • Moores Cancer Center at the UC San Diego Health

    San Diego, California, 92037

  • Adventist Health System/Sunbelt,Inc

    Seattle, Washington, 98109

  • Medical Oncology Associates, PS

    Spokane, Washington, 99204

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Novant Health Cancer Institute - Forsyth (Medical Oncology)

    Winston-Salem, North Carolina, 27103

Other trials in United States

Spain19 sites

  • H. Vall d'Hebron

    Barcelona

  • START Barcelona HM Nou Delfos

    Barcelona

  • Hospital Duran i Reynals - ICO L Hospitalet

    L'Hospitalet de Llobregat

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario Lucus Augusti

    Lugo

  • Clinica Universidad de Navarra

    Madrid

  • HM CIOCC Hospital Universitario HM Sanchinarro

    Madrid

  • Hospital Clinico San Carlos

    Madrid

  • Hospital General Universitario Gregorio Maran

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • MD Anderson Cancer Center Madrid

    Madrid

  • START Madrid - Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Clinica Universidad de Navarra

    Pamplona

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela

  • Hospital Virgen del Rocio

    Seville

  • Hospital Clinico Universitario de Valencia

    Valencia

Other trials in Spain

South Korea7 sites

  • Chungbuk National University Hospital

    Cheongju-si

  • Jeonbuk National University Hospital

    Jeonju

  • Gachon University Gil Medical Center

    Namdong

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

  • Pusan National University Yangsan Hospital

    Yangsan

Other trials in South Korea

Taiwan7 sites

  • Chang Gung Memorial Hospital (CGMH) - Kaohsiung Branch

    Kaohsiung City

  • Kaohsiung Medical University Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • Taipei Medical University Hospital

    Taipei

  • Taipei Veterans General Hospital, VGHTPE

    Taipei

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan

Other trials in Taiwan

Germany5 sites

  • Nationales Centrum fr Tumorerkrankungen NCT

    Heidelberg

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen

  • Department of Dermatology, University of Mainz

    Mainz

  • Universitätsmedizin Mannheim Dermatologie

    Mannheim

  • Universitaetsklinikum Wuerzburg

    Würzburg

Other trials in Germany

Italy4 sites

  • Azienda Ospedaliera Spedali Civili di Brescia

    Brescia

  • Azienda Ospedaliera S.Croce e Carle Cuneo

    Cuneo

  • Istituto Nazionale dei Tumori

    Milan

  • Istituto Clinico Humanitas

    Rozzano

Other trials in Italy

Denmark3 sites

  • Rigshospitalet (Copenhagen University Hospital)

    Copenhagen

  • Herlev University Hospital

    Herlev

  • University Hospital of Southern Denmark, Vejle Hospital

    Vejle

Other trials in Denmark

France3 sites

  • Centre hospitalier Universitaire de Bordeaux

    Bordeaux

  • Centre Antoine Lacassagne

    Nice

  • Gustave Roussy

    Villejuif

Other trials in France

Israel2 sites

  • Rabin Medical Center

    Petah Tikva

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Georgia1 site

  • ARENSIA Research Clinic at the Research Institute of Clinical Medicine

    Tbilisi

Other trials in Georgia

Moldova1 site

  • ARENSIA Research Clinic at the Oncology Institute

    Chisinau

Other trials in Moldova

United Kingdom1 site

  • Royal Marsden NHS Foundation Trust

    Sutton

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

This is an open-label, multicenter phase 1/2 study designed to assess the safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of GEN1042 administered as a monotherapy or in combination in participants with metastatic or locally advanced solid tumors.

Participants will receive either GEN1042 alone, GEN1042 with pembrolizumab, or GEN1042 with pembrolizumab and chemotherapy. All participants will receive active drug; no one will receive placebo.

This trial has 2 parts. The purpose of the first part is to find out if GEN1042 is safe and to find out the best doses of GEN1042 to use. The purpose of the second part is to give GEN1042 to more participants to see how well the dose(s) of GEN1042 selected in the first part work against cancer with GEN1042 when given alone or in combination with pembrolizumab or in combination with pembrolizumab and chemotherapy.

Trial details include:

  • The average trial duration will be about 2 years and 4 months.
  • The treatment duration will be up to 2 years (when GEN1042 is combined with pembrolizumab).
  • The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.

A long-term extension phase (LTEP) has been added to allow continued access to trial treatment for up to 2 years from the individual participant's Cycle 1 Day 1 visit.

Being tested
GEN1042, Pembrolizumab, Cisplatin, Carboplatin, 5-FU
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Melanoma, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04083599
Study groupRoleWhat they receive
Monotherapy - Dose Escalation and Dose Expansion PartsExperimentalNot described
Receives: Biological: GEN1042
Combination Therapy - Safety Run-in and Expansion PartsExperimentalNot described
Receives: Biological: GEN1042; Drug: Pembrolizumab; Drug: Cisplatin; Drug: Carboplatin; Drug: 5-FU; Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: Pemetrexed; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation and Safety Run-in Parts: Number of Participants With Dose-Limiting Toxicities (DLTs)

    Toxicities will be graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0

    Measured: First Cycle (21 days)

  2. Dose Expansion: Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with best overall response (BOR) [complete or partial response (PR or CR)] based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by the investigator.

    Measured: Up to approximately 2 years and 4 months

Secondary outcomes (10)

  1. All Parts: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From first dose until the end of the study (approximately 2 years and 4 months)

  2. Dose Escalation: ORR

    ORR is defined as the percentage of participants with BOR (PR or CR) based on RECIST version 1.1 as assessed by the investigator.

    Measured: Up to approximately 2 years and 4 months

  3. All Parts: Duration of Objective Response (DOR)

    DOR is defined as time from the first documentation of objective tumor response (CR or PR) to the date of first progressive disease (PD) or death based on RECIST version 1.1 as assessed by the investigator.

    Measured: Up to approximately 2 years and 4 months

  4. All Parts: Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease (SD) based on RECIST version 1.1 as assessed by the investigator.

    Measured: Up to approximately 2 years and 4 months

  5. All Parts: Progression-Free Survival (PFS)

    PFS is defined as the time from Day 1 in Cycle 1 to the first documented progression or death due to any cause based on RECIST version 1.1 as assessed by the investigator.

    Measured: Up to approximately 2 years and 4 months

  6. All Parts: Overall Survival (OS)

    OS is defined as time from Day 1 in Cycle 1 to death due to any cause.

    Measured: Up to approximately 2 years and 4 months

  7. All Parts: Area Under the Concentration-Time Curve (AUC) of GEN1042

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 2 years)

  8. All Parts: Maximum Observed Plasma Concentration (Cmax) of GEN1042

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 2 years)

  9. All Parts: Half-life (t½) of GEN1042

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 2 years)

  10. All Parts: Number of Participants With Anti-drug Antibody (ADA) Response to GEN1042

    Serum samples will be screened for antibodies binding to GEN1042 and the titer of confirmed positive samples will be reported.

    Measured: Predose and postdose at multiple timepoints up to end of treatment (approximately 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study start17 Sep 2019
  3. Primary completion30 Dec 2025
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04083599
Sponsor's protocol ID
GCT1042-01
Other IDs
2018-003716-47, IRAS ID: 263292, MOH_2023-07-31_012855, 2023-508526-10, RECF-005255, Rg13-835_03.08.2023, 2023-508526-10-00, 1129008831
Status last verified
Aug 2026
First submitted
6 Sep 2019
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bajaj G, Shchelokov D, Demin O Jr, Adams HC 3rd, Feng Y, Gibiansky L, van der Lee S, Johri A, Belete M, Muik A, Panorchan P, Tureci O, Sahin U, Ahmadi T, Gupta M, Demin O, Thalhauser C. Dose Selection for DuoBody(R)-CD40x4-1BB (GEN1042/BNT312) Using a mPBPK/RO Model Leveraging Preclinical and Clinical Data. Clin Pharmacol Ther. 2025 Aug;118(2):418-427. doi: 10.1002/cpt.3677. Epub 2025 May 10.

    PubMed 40347227

  • Muik A, Adams 3rd HC, Gieseke F, Altintas I, Schoedel KB, Blum JM, Sanger B, Burm SM, Stanganello E, Verzijl D, Spires VM, Vascotto F, Toker A, Quinkhardt J, Fereshteh M, Diken M, Satijn DPE, Kreiter S, Ahmadi T, Breij ECW, Tureci O, Sasser K, Sahin U, Jure-Kunkel M. DuoBody-CD40x4-1BB induces dendritic-cell maturation and enhances T-cell activation through conditional CD40 and 4-1BB agonist activity. J Immunother Cancer. 2022 Jun;10(6):e004322. doi: 10.1136/jitc-2021-004322.

    PubMed 35688554

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GEN1042, Pembrolizumab and Cisplatin in people with Malignant Solid Tumor and Non-Small Cell Lung Cancer (NSCLC), run by Genmab at 76 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Spain, South Korea, Taiwan, Germany and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation and Safety Run-in Parts: Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: First Cycle (21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04083599, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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