BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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
Sponsor: Darren Sigal, MD
You may qualify if…
- ✓ 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) per a FDA-approved assay (Caris MI Cancer Seek®, FoundationOne® CDx, or Tempus xT CDx).
- ✓ 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
- ✓ ECOG performance status 0-1 and life expectancy ≥12 weeks
- ✓ Adequate organ and marrow function:
- ✓ ANC ≥1.5 × 10⁹/L
- ✓ Platelets ≥100 × 10⁹/L
You may not qualify if…
- ✕ 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
- ✕ Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke, unstable angina, NYHA class ≥III heart failure, uncontrolled arrhythmias) or QTc \>480 ms
- ✕ Active or untreated brain metastases or leptomeningeal disease
- ✕ Concurrent malignancy requiring treatment or active within 2 years (with protocol-specified exceptions)
- ✕ Receipt of prior anti-cancer therapy within protocol-defined washout periods, including:
Where it's recruiting
La Jolla
Source: ClinicalTrials.gov · NCT07550088 · last updated 2026-08-10