Botensilimab Phase 3 Primary Completion for Colorectal Adenocarcinoma

Primary completion for the PHASE3 trial (NCT07152821) of Botensilimab in combination with Balstilimab was recorded on 2026-07-13. This study, investigating therapy for chemo-refractory, unresectable colorectal adenocarcinoma, was subsequently TERMINATED after enrolling 21 participants.

Background

Botensilimab and Balstilimab were being investigated as immunotherapy drugs for patients with colorectal cancer that could not be surgically removed and was refractory to chemotherapy. The study aimed to assess if this combination could improve patient survival, quality of life, or tumor response.

Trial design

The study, identified as NCT07152821, was a PHASE3 trial with an enrollment of 21 participants. It focused on patients with Colorectal Cancer, specifically those with chemo-refractory, unresectable colorectal adenocarcinoma. The intervention involved a combination of botensilimab and balstilimab, compared against Best Supportive Care. The primary objectives included evaluating overall survival, quality of life, tumor growth and shrinkage, and identifying predictive biomarkers, as well as confirming safety and metabolism of the drugs. Specific primary outcome measures were not detailed in the available data.

Key results

No key measurements or analyses were reported for this trial. The study was recorded as TERMINATED, indicating that it concluded without providing outcome data as initially planned.

What this means

The primary completion status, followed by the termination of the PHASE3 trial for Botensilimab and Balstilimab, means that no efficacy or safety data from this specific study will be available to inform the treatment of chemo-refractory, unresectable colorectal adenocarcinoma. The reasons for termination are not specified in the available data, but such an event typically prevents the collection of conclusive results regarding the investigational therapy.

Source

This information was sourced from ClinicalTrials.gov, documenting the primary completion and termination of trial NCT07152821 on 2026-07-13. The study details are available on clinicaltrials.gov.