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

Official record

Identifier

NCT07550088

Recruiting locations

country

United States

Interventions studied

Balstilimab (BAL)Botensilimab (BOT)agenT-797

Lead sponsor

Darren Sigal, MD

Target enrolment

17 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Apr 24, 2026

Last updated on the registry

Aug 10, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

Inclusion Criteria:

* 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 Criteria:

* 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

Indexed under

Liver Cancer