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Monoclonal Antibodies

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

Phase 1
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 91 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is for people with newly diagnosed colorectal cancer who are about to have surgery. It tests two combinations of medicines that help the immune system fight cancer. The study aims to see if these medicines are safe and if they can shrink the tumor.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 91 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 91 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite endpoint: Proportion of patients with at least one occurrence of a safety or feasibility event
Secondary study objectives
Pathological response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: Pembrolizumab + BI 765063Experimental Treatment2 Interventions
Group II: Cohort A: Ezabenlimab + BI 765063Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 765063
2020
Completed Phase 1
~20
Pembrolizumab
2017
Completed Phase 3
~3150

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,551 Previous Clinical Trials
15,858,023 Total Patients Enrolled

Media Library

Ezabenlimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05446129 — Phase 1
Colorectal Cancer Research Study Groups: Cohort A: Ezabenlimab + BI 765063, Cohort B: Pembrolizumab + BI 765063
Colorectal Cancer Clinical Trial 2023: Ezabenlimab Highlights & Side Effects. Trial Name: NCT05446129 — Phase 1
Ezabenlimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05446129 — Phase 1
~1 spots leftby Dec 2025