A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors
About the study
The main purpose is to assess the safety and clinical activity of GEN1042 in combination with radiotherapy or GEN1042 in combination with radiotherapy and pembrolizumab as a treatment option for participants with metastatic solid tumors.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Key Inclusion Criteria:
- Participants with histologically confirmed non-central nervous system (CNS) solid tumor that is metastatic and for whom there is no available standard therapy.
- At least 18 years of age.
- Signed informed consent prior to any screening procedures.
- Measurable disease according to RECIST v1.1.
- Life expectancy of >3 months.
- Qualify for palliative radiotherapy as an available option for disease management.
- Eastern Cooperative Oncology Group (ECOG) 0-1.
- Normal or adequate liver, renal, cardiac and bone marrow function.
EXCLUSION CRITERIA
Key Exclusion Criteria:
- Prior malignancy except for non-melanoma skin cancers and in situ cancers.
- Condition contraindicating radiotherapy.
- Rapidly progressing disease.
- Active, known or suspected autoimmune disease.
- History of non-infectious pneumonitis that required steroids or currently has pneumonitis.
- Contraindications to the use of pembrolizumab.
- Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment.
- Received an allogeneic tissue/solid organ transplant.
- Active infection requiring systemic therapy.
Note: Other protocol defined inclusion and exclusion criteria may apply.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Non-CNS Tumor
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
88
Est. Completion Date
Jul 31, 2026
Treatment type
Interventional
Sponsor
Genmab
ClinicalTrials.gov identifier
NCT05491317
Study number
GCT1042-02
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?