Status:
ACTIVE_NOT_RECRUITING
GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
Lead Sponsor:
Genmab
Collaborating Sponsors:
BioNTech SE
Conditions:
Malignant Solid Tumor
Non-Small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 tr...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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/Exclusion criteria may apply.
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04083599
Start Date
September 17 2019
End Date
November 1 2026
Last Update
December 2 2025
Active Locations (76)
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1
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
2
Cancer & Blood Specialty Clinic
Los Alamitos, California, United States, 90720
3
Moores Cancer Center at the UC San Diego Health
San Diego, California, United States, 92037
4
Yale University Cancer Center
New Haven, Connecticut, United States, 06520