GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
NCT ID: NCT04083599
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
350 participants
INTERVENTIONAL
2019-09-17
2026-11-30
Brief Summary
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Detailed Description
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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 3 years.
* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Monotherapy - Dose Escalation and Dose Expansion Parts
GEN1042
Intravenous
Combination Therapy - Safety Run-in and Expansion Parts
GEN1042
Intravenous
Pembrolizumab
Intravenous
Cisplatin
Intravenous
Carboplatin
Intravenous
5-FU
Intravenous
Gemcitabine
Intravenous
Nab paclitaxel
Intravenous
Pemetrexed
Intravenous
Paclitaxel
Intravenous
Interventions
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GEN1042
Intravenous
Pembrolizumab
Intravenous
Cisplatin
Intravenous
Carboplatin
Intravenous
5-FU
Intravenous
Gemcitabine
Intravenous
Nab paclitaxel
Intravenous
Pemetrexed
Intravenous
Paclitaxel
Intravenous
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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Study Official
Role: STUDY_DIRECTOR
Genmab
Locations
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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
Universitätsmedizin 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
Countries
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References
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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.
Other Identifiers
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2018-003716-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IRAS ID: 263292
Identifier Type: REGISTRY
Identifier Source: secondary_id
MOH_2023-07-31_012855
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-508526-10
Identifier Type: OTHER
Identifier Source: secondary_id
RECF-005255
Identifier Type: OTHER
Identifier Source: secondary_id
Rg13-835_03.08.2023
Identifier Type: OTHER
Identifier Source: secondary_id
2023-508526-10-00
Identifier Type: CTIS
Identifier Source: secondary_id
GCT1042-01
Identifier Type: -
Identifier Source: org_study_id
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