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Study of Balstilimab, Botensilimab, and agenT-797 for Metastatic Colorectal Cancer

This study is testing a combination of three drugs – balstilimab, botensilimab, and agenT-797 – for adults with metastatic colorectal cancer that has spread to the liver. This cancer is also described as microsatellite stable (pMMR), meaning it doesn't respond well to some common immunotherapies. The goal is to see if this combination is safe and can shrink tumors. All 17 participants will receive the study treatment. Researchers will measure how many participants experience tumor shrinkage (Overall Response Rate) and what side effects occur. To join, you must have metastatic colorectal cancer with liver metastases, be at least 18 years old, and have a tumor confirmed as microsatellite stable (pMMR).

Study design
This is a single-arm study, meaning all 17 participants will receive the same combination treatment. It is a Phase II trial, focused on safety and effectiveness.
What's involved
Balstilimab is given intravenously (IV) on Days 1, 15, 29 of each 42-day cycle for up to 9 cycles. Botensilimab is given IV on Day 1 of Cycles 1 through 4. agenT-797 is given IV on Day 1 of Cycle 1 and Day 15 of Cycle 2.
Compensation
Not stated in the trial record.
Follow-up
Tumor shrinkage will be measured from enrollment until the disease progresses or study treatment ends, for up to approximately 12 months.

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NCT07550088

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Darren Sigal, MD
~17 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Balstilimab (BAL)Botensilimab (BOT)agenT-797

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over From enrollment until first documented disease progression or end of study treatment (up to approximately 12 months).

Conditions

Colorectal Cancer Metastatic

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Where it's being run

1 sites across 1 states
California1

Who to contact

Darren Sigal Principal Investigator, MD
[email protected]
858-554-8788
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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Overall Response Rate (ORR)From enrollment until first documented disease progression or end of study treatment (up to approximately 12 months).

    ORR, defined as the proportion of participants whose best overall response (BOR) is either Complete Response (CR) or Partial Response (PR) per RECIST v1.1.