A Safety and Antitumor Activity Trial of Immunoradiotherapy Combinations as a Treatment Option for Subjects With Metastatic Solid Tumors
- Conditions
- Non-CNS Tumor
- Registration Number
- NCT05491317
- Lead Sponsor
- Genmab
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 88
Key Inclusion Criteria:<br><br> - Participants with histologically confirmed non-central nervous system (CNS) solid<br> tumor that is metastatic and for whom there is no available standard therapy.<br><br> - At least 18 years of age.<br><br> - Signed informed consent prior to any screening procedures.<br><br> - Measurable disease according to RECIST v1.1.<br><br> - Life expectancy of >3 months.<br><br> - Qualify for palliative radiotherapy as an available option for disease management.<br><br> - Eastern Cooperative Oncology Group (ECOG) 0-1.<br><br> - Normal or adequate liver, renal, cardiac and bone marrow function.<br><br>Key Exclusion Criteria:<br><br> - Prior malignancy except for non-melanoma skin cancers and in situ cancers.<br><br> - Condition contraindicating radiotherapy.<br><br> - Rapidly progressing disease.<br><br> - Active, known or suspected autoimmune disease.<br><br> - History of non-infectious pneumonitis that required steroids or currently has<br> pneumonitis.<br><br> - Contraindications to the use of pembrolizumab.<br><br> - Condition requiring systemic treatment with either corticosteroids or other<br> immunosuppressive medications within 14 days of first treatment.<br><br> - Received an allogeneic tissue/solid organ transplant.<br><br> - Active infection requiring systemic therapy.<br><br>Note: Other protocol defined inclusion and exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants with Dose Limiting Toxicities (DLTs);Part 2: Number of Participants with Abscopal Response in Non-irradiated Target Lesions
- Secondary Outcome Measures
Name Time Method Parts 1 and 2: Objective Response Rate (ORR);Parts 1 and 2: Duration of Response (DOR);Parts 1 and 2: Disease Control Rate (DCR);Parts 1 and 2: Progression Free Survival (PFS);Parts 1 and 2: One- year Overall Survival (OS);Part 1: Number of Participants With Abscopal Response in Non-irradiated Target Lesions;Parts 1 and 2: Number of Participants with Adverse Events (AEs);Parts 1 and 2: Area Under the Concentration-time Curve (AUC) of GEN1042;Parts 1 and 2: Maximum (Peak) Plasma Concentration (Cmax);Parts 1 and 2: Elimination Half-life (T1/2) of GEN1042;Parts 1 and 2: Number of Participants with Anti-drug Antibodies (ADAs)