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RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer

Study acronym: RECTIFY-1
StatusRecruiting
PhasePhase 2
Started2026-09
View on ClinicalTrials.gov ↗

Amendment history

2026-08-17
Study Status, Contacts/Locations v1
Recruitment opened
Study sitesdetails revised at 3 of 3 sites
2026-07-29
Original filing
This is a multi-site, prospective, non-randomized phase 2 study evaluating neoadjuvant botensilimab in combination with balstilimab for patients with microsatellite stable (MSS) / mismatch repair proficient (MMRp) early rectal cancer staged T1-T2 N0 by MRI and considered candidates for surgical resection without standard neoadjuvant therapies. Participants will receive a single IV dose of botensilimab on Day 1 followed by balstilimab IV every 2 weeks for up to 6 months, with tumor response assessments during treatment and follow-up afterward.
Trial Details
NCT Number NCT07735624
Lead Sponsor Dana-Farber Cancer Institute
Collaborators: Agenus Inc., Gateway for Cancer Research
Conditions Early Rectal Cancer, Stage I Rectal Cancer, Microsatellite Stable Rectal Carcinoma
Enrollment 16 participants
Start Date 2026-09
Primary Completion 2027-01-01 (estimated)
Study Completion 2032-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-18