Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06882746 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusTerminated
PhasePhase 1
Started2025-03-28
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Trial terminated: Sponsor decision
Final enrollment: 14 participants (planned 135)
2026-08-20
Study Status, Contacts/Locations v13
Enrollment closed, study ongoing
Trial sites expanded: 3 → 6 locations
Primary completion moved earlier: 2026-12-11 → 2026-09-09
Completion moved earlier: 2027-05-12 → 2026-09-09
2026-03-16
Study Status, Contacts/Locations v12
Study sitesdetails revised at 2 of 3 sites
2026-03-05
Active, Not Recruiting→Recruiting Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing, References v11
Trial statusActive, Not Recruiting→Recruiting
Eligibility criteria+1 characters
Inclusion criteria: SignedFor all patients, signed and dated informed consent form (ICF)2/main ICF for all patients describing the study in accordance with International Counc [...]
Secondary endpointsdetails revised at 1 of 6 entries
Study sitesdetails revised at 3 of 3 sites
2025-12-08
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 3 of 3 sites
Show 9 earlier versions
2025-09-01
Study Status, Contacts/Locations v9
Study sites15→3
2025-08-04
Study Status, Eligibility, Contacts/Locations v8
Eligibility criteria-36 characters
[...] ent 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.
Study sites15 entries, revised
Klinikum rechts der Isar der Technischen Universität München AÖR
2025-07-30
Study Status, Study Description v7
Re-verified, no change to tracked fields
2025-07-21
Study Status, Contacts/Locations v6
Study sites14→15
2025-07-07
Study Status, Contacts/Locations v5
Study sites7→14
2025-06-23
Study Status, Contacts/Locations v4
Study sitesdetails revised at 6 of 7 sites
2025-05-26
Study Status, Study Design, Contacts/Locations v3
Enrollment target100→135
Study sites5→7
2025-04-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-04-01→confirmed 2025-03-28
Study sites0→5
2025-03-21
Study Status, Arms and Interventions v1
Re-verified, no change to tracked fields
2025-03-17
Original filing
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.
Trial Details
NCT Number NCT06882746
Lead Sponsor Boehringer Ingelheim
Conditions Colorectal Carcinoma, Gastric Carcinoma, Pancreatic Ductal Adenocarcinoma
Enrollment 14 participants
Start Date 2025-03-28
Primary Completion 2026-09-08 (estimated)
Study Completion 2026-09-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-24