Trial results for the Phase 1 study (NCT05446129) investigating pembrolizumab in combination with BI 765063 for people with colorectal cancer were posted on ClinicalTrials.gov on 2025-03-13. The terminated study, which enrolled 2 participants, reported 0% of patients experiencing safety or feasibility events and a 1% pathologic response rate in both treatment arms.

Background

The study investigated pembrolizumab or ezabenlimab, each combined with BI 765063, in people with newly diagnosed colorectal cancer who were scheduled for surgery. The tested medicines are antibodies that may help the immune system fight cancer, and the study aimed to assess tolerability and tumor changes.

Trial design

The study (NCT05446129) was a Phase 1 trial, which was subsequently terminated. It enrolled 2 participants with newly diagnosed colorectal cancer. Participants were assigned to receive either ezabenlimab plus BI 765063 or pembrolizumab plus BI 765063 prior to surgery. The study's purpose was to evaluate how well participants tolerated the treatment and to observe tumor changes.

Key results

The trial results, based on an enrollment of 2 participants, provided data on safety, pathologic response, and time to surgery. For the outcome of "Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event":

Regarding "Pathologic Response (PR)":

For "Time From Administration of Trial Treatment to Surgery":

What this means

The results from this Phase 1 trial, which was terminated after enrolling only 2 participants, provide very limited data on the safety and preliminary efficacy of pembrolizumab or ezabenlimab in combination with BI 765063 for colorectal cancer. While 0% safety events and a 1% pathologic response were reported for both arms, the extremely small sample size means these findings cannot be generalized or used to draw definitive conclusions about the treatments' potential.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05446129, titled "A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery," were posted on 2025-03-13 on clinicaltrials.gov.