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A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

NCT06843434 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-05

No results posted yet for this study

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

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.

DRUG

Balstilimab

Balstilimab is a fully human monoclonal IgG4 antibody designed to block PD-1 binding to PD-L1 and PD-L2

Sponsors & Collaborators

Principal Investigators

  • Andrea Cercek, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-20
Primary Completion
2028-02-20
Completion
2028-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06843434 on ClinicalTrials.gov