Not Yet RecruitingEarly Phase 1

Botensilimab, Balstilimab, and SBRT in Colorectal Cancer

United States15 participantsStarted 2026-06

Plain-language summary

This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer (CRC) with liver metastasis.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓-Woman of childbearing potential (WOCBP) and men with WOCBP partners must agree to use highly effective contraceptive measures starting at screening through 5 months (180 days) after the last dose of balstilimab and/or botensilimab.

Exclusion criteria

✕-EXCEPTIONS: Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \>10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
✕-EXCEPTION: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed.

What they're measuring

Incidence of dose limiting radiation-related toxicities

Timeframe: Day 1 of treatment through 30 days after completion of radiation therapy (radiation therapy is 2-3 weeks), up to 60 days.

Trial details

NCT IDNCT07128355

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-01

Contact for this trial

Aparna R. Parikh, MD

617-724-4000 aparna.parikh@mgh.harvard.edu

View on ClinicalTrials.gov More Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis trials