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

Phase 1

Recruiting

• Conditions: Colorectal Carcinoma; Gastric Carcinoma; Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: BI 765049

• Registration Number: NCT06882746
• Lead Sponsor: Boehringer Ingelheim

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 but no longer than 3 years.

During this time, 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 1 week after the first treatment with the intended dose.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Study First Posted: 2025-03-25
• Study Start: 2025-03-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-12-11
• Study Completion: 2027-05-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1 (Administration Regimen A)	BI 765049	-
Part 2 (Administration Regimen B)	BI 765049	-

Primary Outcome Measures

Name	Time	Method
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period	up to 36 months

Secondary Outcome Measures

Name	Time	Method
Objective response (OR)	up to 36 months	OR defined as the best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to response evaluation criteria in solid tumors (RECIST) 1.1 from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, or treatment discontinuation as assessed by investigator review
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
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations	up to 20 days

Trial Locations

Locations (5)

Valkyrie Clinical Trials; 🇺🇸 Los Angeles, California, United States

Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Technische Universität Dresden; 🇩🇪 Dresden, Germany

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clínico de Valencia; 🇪🇸 Valencia, Spain