BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases
ConditionColorectal Cancer Metastatic
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDarren Sigal, MD
About this trial
The goal of this clinical trial is to learn whether the combination of balstilimab, botensilimab, and agenT-797 is safe and effective in treating adults with previously treated metastatic colorectal cancer that is microsatellite stable (pMMR) and has spread to the liver.
The main questions it aims to answer are:
* What proportion of participants experience tumor shrinkage (objective response rate) based on imaging assessments? * What side effects occur with this combination treatment, including immune-related and cytokine-related reactions?
All participants in this study will receive the combination treatment. There is no comparison group.
Participants will:
* Receive balstilimab, botensilimab, and agenT-797 in repeating 42-day treatment cycles * Undergo imaging scans (such as CT or MRI) to assess tumor response * Have blood samples collected to monitor safety and evaluate biomarkers * Provide tumor tissue samples for research * Be monitored for side effects throughout the study * Participate in follow-up visits to assess survival after treatment completion
Eligibility criteria
Qualifiers
Adults ≥18 years of age with histologically confirmed metastatic colorectal cancer with liver metastases, including evidence of active liver disease if previously treated locally
At least one measurable lesion per RECIST v1.1, with ≥1 target lesion in the liver
Tumor confirmed as microsatellite stable (MSS)/proficient mismatch repair (pMMR)
Received ≥1 prior line of systemic therapy including fluorouracil, oxaliplatin, and irinotecan (not necessarily in combination), and prior EGFR inhibitor or bevacizumab if eligible, unless contraindicated
Disqualifiers
Tumor is dMMR/MSI-high
Prior treatment with PD-1, PD-L1, CTLA-4 inhibitors, or other immunotherapy agents
Evidence of bowel obstruction, impending obstruction, or recent obstruction (within 3 months)
Refractory ascites requiring frequent paracentesis or recent escalation of diuretics
Trial design
Treatments tested in this trial
- Balstilimab (BAL)
- Botensilimab (BOT)
- agenT-797
Treatment groups
17 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov