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

NCT05446129 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: 1502-0001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study is open to people with newly diagnosed colorectal cancer. People who are scheduled for surgery can participate. People either get a medicine called BI 765063 combined with ezabenlimab or combined with pembrolizumab in preparation of the upcoming surgery. The tested medicines in this study are antibodies that may help the immune system fight cancer. The purpose of this study is to find out how well people with early colorectal cancer can tolerate treatment with these medicines. The study also looks at whether the tumor changes. Participants are put into 2 groups. One group gets ezabenlimab and BI 765063. The other group gets pembrolizumab and BI 765063. All participants receive the study medicines as 2 subsequent infusions into a vein on a single day. Participants are in the study for about 4 months. During this time, they visit the study site about 5 times. The doctors check the health of the participants and note any health problems that could have been caused by ezabenlimab, pembrolizumab, or BI 765063. The doctors also check whether these health problems lead to a delay of the planned surgery.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event

  Safety: A safety event was defined as any grade 3 or higher adverse events (AEs; according to National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) related to study treatments at any point within the follow-up period following the administration of study treatments. Feasibility (delay in surgery): A feasibility event or delay in surgery was defined as any treatment related AE leading to delay in surgery, which was scheduled to take place between 2 weeks and up to 6 weeks following the study treatment administration will be considered as a relevant AE for this endpoint.

  Up to 91 days after drug administration.

Secondary Outcomes (3)

• Pathologic Response (PR)

  Up to 91 days after drug administration.

• Time From Administration of Trial Treatment to Surgery

  Up to 91 days after drug administration.

• Radiographic Response Rate

  Up to 91 days after drug administration.

Study Arms (2)

Cohort A: Ezabenlimab + BI 765063

EXPERIMENTAL

Drug: Ezabenlimab; Drug: BI 765063

Cohort B: Pembrolizumab + BI 765063

EXPERIMENTAL

Drug: BI 765063; Drug: Pembrolizumab

Interventions

Ezabenlimab DRUG

Ezabenlimab

Cohort A: Ezabenlimab + BI 765063

BI 765063 DRUG

BI 765063

Cohort A: Ezabenlimab + BI 765063; Cohort B: Pembrolizumab + BI 765063

Pembrolizumab DRUG

Pembrolizumab

Cohort B: Pembrolizumab + BI 765063

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Ability to understand and the willingness to sign a written informed consent.
• Male or female aged = 18 years at the time of informed consent form (ICF) signature.
• Patients with histological diagnosis of resectable colorectal Cancer (CRC), or radiographic/visual findings highly suggestive, with planned confirmatory biopsy.
• CRC lesions must be at least 1 centimeter (cm) in largest diameter and amenable to endoscopic biopsy.
• Patient must be willing and able to have endoscopic biopsy (Goal 3-6 core-needle or surgical/endoscopic biopsies, final number to be determined by the physician performing the procedure as safe) of tumor prior to initiation of therapy.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The exception will be patients with long term disability (such as cerebral palsy) that is unlikely to significantly affect their response to therapy.
• Patient is determined to be a surgical candidate for resection of their tumor.
• Adequate organ and marrow function as defined in the protocol.

You may not qualify if:

• Patients who are deemed to be at high risk for colonic obstruction and/or perforation per investigator assessment.
• Patients eligible for neoadjuvant therapy (chemotherapy, radiotherapy, chemoradiotherapy) as standard of care.
• Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to administration of trial medication.
• Patients who must or wish to continue the intake of restricted medications (as defined in the protocol) or any drug considered likely to interfere with the safe conduct of the trial.
• Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant).
• Previous enrolment in this trial.
• Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
• Patients who have had chemotherapy or radiotherapy within 6 months prior to entering the study for a different primary tumor, or those that have received locoregional therapy (radiation, chemoembolization, etc.) for the target lesion that will be biopsied and subsequently resected. Previous therapy for a different cancer (a different primary) is acceptable.
• Prior immune checkpoint inhibitor therapy.
• Patients with metastatic or recurrent disease, for which the intent of surgery would not be curative.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

The trial was terminated early due to the sponsor's decision.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

018002430127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 6, 2022
• Study Start: September 27, 2022
• Primary Completion: August 11, 2023
• Study Completion: November 8, 2023
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)