BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases

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 co

Trial Details

NCT ID
NCT07550088
Phase
PHASE2
Sponsor
Darren Sigal, MD
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Balstilimab (BAL)
  • Botensilimab (BOT)
  • agenT-797
Locations (sample)
  • La Jolla, California, United States|32.84727,-117.2742

Key Eligibility Criteria

  • Adults ≥18 years of age with histologically confirmed metastatic colorectal cancer with liver metastases, including evidence of active liver diseas…
  • 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® CD…
  • Received ≥1 prior line of systemic therapy including fluorouracil, oxaliplatin, and irinotecan (not necessarily in combination), and prior EGFR inh…

For full eligibility, visit ClinicalTrials.gov.

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