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NCT Number: NCT06882746

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

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.

Recruiting

Interested in participating?

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Key information

Conditions

Colorectal Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastric Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Ductal Adenocarcinoma Rectal Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Valkyrie Clinical Trials, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients with advanced, unresectable, and/or metastatic disease. Further inclusion criteria apply.

Exclusion criteria

  • 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.

Further exclusion criteria apply.

Treatment and study plan

BI 765049

Drug

BI 765049

Primary outcomes

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

    Time frame: up to 36 months

Secondary outcomes

  1. Objective response (OR)

    Time frame: 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, loss to follow-up, or withdrawal of consent.

  2. Occurrence of DLTs and adverse events during the entire treatment period

    Time frame: up to 36 months

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

    Time frame: up to 4 days

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

    Time frame: up to 20 days

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

    Time frame: up to 4 days

  6. Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations

    Time frame: up to 20 days

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase I, Open-label, Non-randomised, Multi-center Dose Escalation Trial of BI 765049 Administered by Parenteral Route in Patients With Advanced, Unresectable, and/or Metastatic Colorectal Carcinoma (CRC), Gastric Carcinoma (GC), or Pancreatic Ductal Adenocarcinoma (PDAC) to Determine the MTD and the RP2D and to Determine the Dosing Regimen for Further Development of BI 765049

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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