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

Source: https://onco.cc/trials/nct07735624/  
OnCo record `nct07735624` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of botensilimab and balstilimab in colorectal cancer, run by Dana-Farber Cancer Institute, now recruiting.

## Summary

RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer is a phase 2, interventional study registered as NCT07735624 by Dana-Farber Cancer Institute, with a registry enrolment figure of 16 participants, started 2026-09 and due to reach its primary completion in 2027-01-01. Interventions recorded: Botensilimab; Balstilimab. Conditions listed: Early Rectal Cancer; Stage I Rectal Cancer; Microsatellite Stable Rectal Carcinoma. Primary outcome: Complete response (cCR plus nCR with pCR at resection) within 6 months from initiation of therapy or nCR with pathologic complete response (pCR) with TES. Colorectal eligibility wording from the registry: "* Histologically confirmed diagnosis of early-rectal cancer clinically staged T1-T2 N0 M0 by MRI (American Joint Committee on Cancer (AJCC) staging 8th edition, 2017)". Sites: United States. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-24
- Also known as: RECTIFY-1
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT07735624
- Phase: 2
- Setting: A Phase 2 Study of the Safety and Efficacy of Neoadjuvant Botensilimab in Combination With Balstilimab in the Treatment of Microsatellite Stable / Mismatch Repair Proficient Early Rectal Cancer (RECTIFY-1)
- Sponsor: Dana-Farber Cancer Institute
- Enrolled: 16

## Sources

- ClinicalTrials.gov NCT07735624: https://clinicaltrials.gov/study/NCT07735624

## Connected records

- cancers: [Mismatch-repair deficient (MSI-high) colorectal cancer](https://onco.cc/cancers/msi-high-colorectal/), [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Balstilimab](https://onco.cc/drugs/balstilimab/), [Botensilimab](https://onco.cc/drugs/botensilimab/)
- companies: [Agenus](https://onco.cc/companies/agenus/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct07735624.json