GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors (NCT04083599) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
United States350 participantsStarted 2019-09-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-canc…
What they're measuring
1
Dose Escalation and Safety Run-in Parts: Number of Participants With Dose-Limiting Toxicities (DLTs)
Timeframe: First Cycle (21 days)
2
Dose Expansion: Objective Response Rate (ORR)
Timeframe: Up to approximately 2 years and 4 months