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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT06882746
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI 765049 — DRUG
    BI 765049

Study Details

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.

Key Dates

Start date
Mar 28, 2025
Status verified
Mar 2026
Primary completion
Dec 11, 2026
Completion
May 12, 2027

Study Design

Enrollment
135 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (Administration Regimen A)
  • Experimental: Part 2 (Administration Regimen B)

Primary Outcome Measure

Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period [ Time Frame: up to 36 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Valkyrie Clinical TrialsLos AngelesCalifornia90067
Boehringer Ingelheim
[email protected]
833-602-2368
Winship Cancer InstituteAtlantaGeorgia30322
Boehringer Ingelheim
[email protected]
833-602-2368
Hackensack University Medical CenterHackensackNew Jersey07601
Boehringer Ingelheim
[email protected]
833-602-2368

Find similar trials in Los Angeles, CA

By condition
Colorectal cancerPancreatic cancer
By specialty
OncologyGI oncology
By research site
Valkyrie Clinical Trials· Los Angeles, CAWinship Cancer Institute· Atlanta, GAHackensack University Medical Center· Hackensack, NJ

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