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

NCT07735624 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-08-18

No results posted yet for this study

Summary

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.

Conditions

  • Early Rectal Cancer
  • Stage I Rectal Cancer
  • Microsatellite Stable Rectal Carcinoma

Interventions

DRUG

Botensilimab

one IV infusion on Cycle 1 Day 1, over about 30 minutes

DRUG

Balstilimab

IV infusion every 2 weeks on Day 1 of each treatment cycle, over about 30 minutes, for up to 6 months

Sponsors & Collaborators

Principal Investigators

  • Benjamin Schlecher, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-01-01
Completion
2032-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735624 on ClinicalTrials.gov