Botensilimab, Balstilimab, and SBRT in Colorectal Cancer

EARLY_PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

January 31, 2026

Primary Completion Date

January 1, 2027

Study Completion Date

September 30, 2027

Conditions
Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis
Interventions
RADIATION

Stereotactic Body Radiation Therapy (SBRT)

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.

DRUG

Botensilimab

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.

DRUG

Balstilimab

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.

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Agenus Inc.

INDUSTRY

lead

Massachusetts General Hospital

OTHER

NCT07128355 - Botensilimab, Balstilimab, and SBRT in Colorectal Cancer | Biotech Hunter | Biotech Hunter