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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07735624
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Botensilimab — DRUG
    one IV infusion on Cycle 1 Day 1, over about 30 minutes
  • Balstilimab — DRUG
    IV infusion every 2 weeks on Day 1 of each treatment cycle, over about 30 minutes, for up to 6 months

Study Details

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.

Key Dates

First listed
Jul 30, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Jan 1, 2027
Completion
Dec 31, 2032

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Botensilimab + Balstilimab
    Participants receive: * Botensilimab: one IV infusion on Cycle 1 Day 1, over about 30 minutes * Balstilimab: IV infusion every 2 weeks on Day 1 of each treatment cycle, over about 30 minutes, for up to 6 months The protocol specifies: * Botensilimab dose: 75 mg IV once * Balstilimab dose: 240 mg IV every 2 weeks for up to 6 months

Primary Outcome Measure

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 [ Time Frame: From baseline to 6 months from initiation of therapy ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical Center (BIDMC)BostonMassachusetts02215-
Brigham and Women's HospitalBostonMassachusetts02115
Danielle Lindquist
[email protected]
857-215-2000
Benjamin L Schlechter, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02115
Danielle Lindquist
[email protected]
857-215-2000
Benjamin Schlechter, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Beth Israel Deaconess Medical Center (BIDMC)· Boston, MABrigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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