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

Recruiting now · Phase 2

Conditions studied: Colorectal Cancer Metastatic

In brief

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

Key facts

Study ID: NCT07550088
Run by: Darren Sigal, MD
People needed: 17
Starts: 2026-06-10
Expected to finish: 2028-12-01
Last updated by the study team: 2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
Hemoglobin ≥ 9 g/dL
AST/ALT ≤2.5 × ULN
Total bilirubin ≤1.5 × ULN
Creatinine clearance ≥ 40 mL/min, as measured or calculated per local institutional standards.
Albumin ≥3 g/dL
PT/PTT ≤1.5 × ULN
Willing and able to provide written informed consent
Negative pregnancy test for women of childbearing potential
Agreement to use effective contraception during study participation

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:
Cytotoxic, targeted therapy or other investigational therapy within 3 weeks.
Monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or similar therapy, within 4 weeks, or 5 half-lives, whichever is shorter.
Small molecules/tyrosine kinase inhibitors within 2 weeks or less than 5 circulating half-lives of investigational drug.
Known hypersensitivity to study drugs or excipients
History of or active interstitial lung disease or pneumonitis requiring systemic steroids
Prior allogeneic transplant (organ, stem cell, or bone marrow)
Active or recent autoimmune disease requiring systemic treatment
Requirement for systemic corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive therapy within defined windows
Active infection, including HIV, HTLV, HBV, HCV, or other infections requiring systemic therapy
Recent SARS-CoV-2 infection within protocol-defined timeframe
Uncontrolled hypertension, significant proteinuria (UPCR ≥1 g/g), or other clinically significant uncontrolled medical conditions
Non-healing wounds, active bleeding, or uncontrolled thyroid dysfunction
Psychiatric or substance use disorders that may interfere with study participation
Receipt of live or attenuated vaccines within 30 days prior to treatment and while participating in the study
Pregnant or breastfeeding women, or those planning pregnancy during the study

Where it is running

Scripps Clinic Torrey Pines — La Jolla, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.