Botensilimab, Balstilimab, and SBRT in Colorectal Cancer

Conditions

• Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Stereotactic Body Radiation Therapy (SBRT) — RADIATION
  Starting on Day 1 participants will have 2-4 treatments per week for about 2 weeks, with no more than 2 days in a row. This is expected to last about 2 weeks but could last up to 3 weeks.
• Botensilimab — DRUG
  Administered once every 6 weeks by intravenous infusion over about 30 minutes, on Day 1 of Cycles 1-4 (six-week cycles). Administered 30 minutes after balstilimab.
• Balstilimab — DRUG
  Administered once every 2 weeks by intravenous infusion over about 30 minutes, starting on Day 1 of Cycle 1 and continuing for 4 six-week cycles (with botensilimab) followed by up to 14 six-week cycles of balstilimab alone. Participants will receive balstilimab for a total of 18 six-week cycles.

Study Details

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.

Key Dates

Start date

May 12, 2026

Status verified

May 2026

Primary completion

Jan 1, 2027

Completion

Sep 30, 2027

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Stereotactic Body Radiation Therapy (SBRT) + Botensilimab + Balstilimab
  Participants will receive: * standard of care (SOC) SBRT for 2-3 weeks (Cycle 1); * botensilimab, on Day 1 of 6-week cycles (Cycles 1-4); * balstilimab, once every 2 weeks (Cycles 1-18, 6-week cycles).

Primary Outcome Measure

Incidence of dose limiting radiation-related toxicities [ Time Frame: Day 1 of treatment through 30 days after completion of radiation therapy (radiation therapy is 2-3 weeks), up to 60 days. ]

Central Contacts

• Aparna R. Parikh, MD
  617-724-4000
  [email protected]

Locations (1)

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