GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
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
9 other identifiers
interventional
350
12 countries
76
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2019
Longer than P75 for phase_1
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedStudy Start
First participant enrolled
September 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
ExpectedMay 6, 2026
May 1, 2026
6.3 years
September 6, 2019
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
First Cycle (21 days)
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.
Up to approximately 2 years and 4 months
Secondary Outcomes (10)
All Parts: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
From first dose until the end of the study (approximately 2 years and 4 months)
Dose Escalation: ORR
Up to approximately 2 years and 4 months
All Parts: Duration of Objective Response (DOR)
Up to approximately 2 years and 4 months
All Parts: Disease Control Rate (DCR)
Up to approximately 2 years and 4 months
All Parts: Progression-Free Survival (PFS)
Up to approximately 2 years and 4 months
- +5 more secondary outcomes
Study Arms (2)
Monotherapy - Dose Escalation and Dose Expansion Parts
EXPERIMENTALCombination Therapy - Safety Run-in and Expansion Parts
EXPERIMENTALInterventions
Intravenous
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genmablead
- BioNTech SEcollaborator
Study Sites (76)
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508, United States
Cancer & Blood Specialty Clinic
Los Alamitos, California, 90720, United States
Moores Cancer Center at the UC San Diego Health
San Diego, California, 92037, United States
Yale University Cancer Center
New Haven, Connecticut, 06520, United States
ChristianaCare
Newark, Delaware, 19713, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Florida Cancer Affiliates
Ocala, Florida, 34474, United States
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Maryland Oncology Hematology PA
Columbia, Maryland, 21044, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Levine Cancer Center
Charlotte, North Carolina, 28204, United States
Novant Health Cancer Institute - Forsyth (Medical Oncology)
Winston-Salem, North Carolina, 27103, United States
Kaiser Permanente (KP) Oncology/Hematology
Portland, Oregon, 97227, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Lumi Research
Kingwood, Texas, 77339, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84124, United States
Virgina Cancer Specialists
Fairfax, Virginia, 22031, United States
Adventist Health System/Sunbelt,Inc
Seattle, Washington, 98109, United States
Medical Oncology Associates, PS
Spokane, Washington, 99204, 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, 35016, 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, Taiwan
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
Related Publications (1)
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.
PMID: 35688554DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Official
Genmab
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2019
First Posted
September 10, 2019
Study Start
September 17, 2019
Primary Completion
December 30, 2025
Study Completion (Estimated)
November 1, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share