Clinical trial NCT06882746: A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Colorectal Carcinoma
Gastric Carcinoma
Pancreatic Ductal Adenocarcinoma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2025-03-19
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1 and part 2 run in parallel
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

* Signed and dated informed consent form (ICF)2/main ICF for all patients 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 for a study procedure (e.g. biopsy) based on the opinion of the Investigator.

Further exclusion criteria apply.

Primary outcomes:
measure: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
timeFrame: up to 36 months
Secondary outcomes:
measure: Objective response (OR)
timeFrame: up to 36 months
measure: Occurrence of DLTs and adverse events during the entire treatment period
timeFrame: up to 36 months
measure: Maximum measured concentration (Cmax) of BI 765049 after first administration
timeFrame: up to 4 days
measure: Maximum measured concentration (Cmax) of BI 765049 after multiple administrations
timeFrame: up to 20 days
measure: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after first administration
timeFrame: up to 4 days
measure: Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations
timeFrame: up to 20 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Dresden
country: Germany
facility: Technische Universität Dresden
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
Study officials:
References: