Testing different doses of BI 765049 in patients with advanced cancer
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
This study is testing different doses of a new drug called BI 765049 to see how well it works for adults with advanced cancer that can’t be removed by surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 135 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT06882746 on ClinicalTrials.gov |
What this trial studies
This study is designed for adults with advanced cancer of the colon, rectum, stomach, or pancreas that cannot be surgically removed or has metastasized. The primary aim is to determine the highest tolerable dose of the investigational drug BI 765049 and to identify the optimal administration method for future clinical use. Participants will receive BI 765049 at least once every three weeks and will be monitored closely through regular visits, including overnight stays for health assessments and laboratory tests. The study will continue as long as participants benefit from the treatment, up to a maximum of three years.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced, unresectable, or metastatic colorectal, gastric, or pancreatic cancers.
Not a fit: Patients with early-stage cancer that can be surgically removed or those who have not exhausted other treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that enhances the immune system's ability to fight advanced cancers.
How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California and 2 other locations
- Valkyrie Clinical Trials — Los Angeles, California, United States (Recruiting)
- Winship Cancer Institute — Atlanta, Georgia, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.