A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas

NCT06882746 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: 1454-00152024-519301-36-00U1111-1316-8363
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief Summary

This study is open to adults with advanced cancer of the colon, rectum, stomach, or pancreas, that is the cancer cannot be removed by surgery or has spread. People can take part in this study if their previous treatment was not successful, or no other treatment exists. The study aims to find the highest dose for the study medicine called BI 765049 that people with advanced cancer can tolerate. Another purpose is to find the most suitable dose and best way of administration of BI 765049 for further clinical development. BI 765049 may help the immune system fight cancer. Participants receive BI 765049 at least once every 3 weeks. Participants may continue to get BI 765049 treatment as long as they benefit from treatment and can tolerate it. Participants in this study also get additional medication before and after treatment with BI 765049 for better tolerability. If participants take this medication at home, they have daily phone visits. Participants regularly visit the study site. The study visits include several overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. Unwanted effects are any health problems that the doctors think were caused by the study medicine or treatment. To find the highest dose of BI 765049 that participants can tolerate, researchers look at the number of participants with certain severe health problems. These are severe health problems that happen within the time from when a person first receives the intended target dose, until one week after they receive it for the second time.

Conditions

Colorectal Carcinoma; Gastric Carcinoma; Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

  up to 36 months

Secondary Outcomes (6)

• Objective response (OR)

  up to 36 months

• Occurrence of DLTs and adverse events during the entire treatment period

  up to 36 months

• Maximum measured concentration (Cmax) of BI 765049 after first administration

  up to 4 days

• Maximum measured concentration (Cmax) of BI 765049 after multiple administrations

  up to 20 days

• Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after first administration

  up to 4 days

Study Arms (2)

Part 1 (Administration Regimen A)

EXPERIMENTAL

Drug: BI 765049

Part 2 (Administration Regimen B)

EXPERIMENTAL

Drug: BI 765049

Interventions

BI 765049 DRUG

BI 765049

Part 1 (Administration Regimen A); Part 2 (Administration Regimen B)

Eligibility Criteria

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

You may qualify if:

• For all patients, signed and dated informed consent form (ICF)2/main ICF describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
• Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature on the ICFs (ICF1/screening ICF and ICF2/main ICF).
• In US: Patients with a histologically or cytologically confirmed diagnosis of colorectal carcinoma (CRC), gastric carcinoma (GC), or pancreatic ductal adenocarcinoma (PDAC).
• In Europe: Patients with a histologically or cytologically confirmed diagnosis of CRC.

You may not qualify if:

• Patient with a history of a major surgery within 28 days prior to first dose of BI 765049 (major according to the Investigator's and/or Medical Monitor's assessment).
• Previous or concomitant malignancies other than the one treated in this trial within the last 5 years except:
• Effectively treated non-melanoma skin cancers
• Effectively treated carcinoma in situ of the cervix
• Effectively treated ductal carcinoma in situ
• Other effectively treated malignancy that is considered cured by local treatment"
• Patient with known leptomeningeal disease or spinal cord compression due to disease.
• Patient requiring anticoagulant treatment which cannot be safely interrupted, if medically needed based on the opinion of the Investigator.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (3)

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

RECRUITING

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms; Stomach Neoplasms

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; Stomach Diseases

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

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

Model Details: Part 1 and part 2 run in parallel

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 19, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): May 12, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

US (3)