NCT06843434

A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

A Phase II Study of Neoadjuvant Botensilimab and Balstilimab Immunotherapy for Mismatch Repair Proficient Rectal Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT/BAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)/microsatellite stable (MSS) locally advanced rectal adenocarcinoma. The investigators will also find out whether BOT/BAL is an effective treatment when given in combination with standard chemotherapy.

Conditions

• Microsatellite Stable Rectal Carcinoma
• Locally Advanced Rectal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Balstilimab	Balstilimab is a fully human monoclonal IgG4 antibody designed to block PD-1 binding to PD-L1 and PD-L2
DRUG	Botensilimab	Botensilimab is a novel fully human fragment crystallizable (Fc)-engineered immunoglobulin 1 kappa (IgG1κ) anti-CTLA-4 immunoglobulin G1 (IgG1) antagonist antibody that is designed to optimally promote fragment-crystallizable gamma receptor (FcγR) effector functions that are important for enhancing T cell priming and regulatory T cell (Treg) depletion.

Timeline

• Start date: 2025-02-20
• Primary completion: 2028-02-20
• Completion: 2028-02-20
• First posted: 2025-02-25
• Last updated: 2025-12-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study