Colorectal CarcinomaPhase 1NCT06882746
A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas
A Phase 1 study testing BI 765049 in people with Colorectal Carcinoma and Gastric Carcinoma, run by Boehringer Ingelheim at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma, Gastric Carcinoma, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- BI 765049
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 28 Mar 2025to 8 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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"
Show all 9Show fewer
- 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.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Winship Cancer Institute
Atlanta, Georgia, 30322
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Valkyrie Clinical Trials
Los Angeles, California, 90067
Yale Cancer Center
New Haven, Connecticut, 06511
About this study
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
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.
Read more
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.
- Being tested
- BI 765049
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 765049Drug
BI 765049
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Administration Regimen A) | Experimental | Not described Receives: Drug: BI 765049 |
| Part 2 (Administration Regimen B) | Experimental | Not described Receives: Drug: BI 765049 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Measured: up to 36 months
Secondary outcomes (6)
Objective response (OR)
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.
Measured: up to 36 months
Occurrence of DLTs and adverse events during the entire treatment period
Measured: up to 36 months
Maximum measured concentration (Cmax) of BI 765049 after first administration
Measured: up to 4 days
Maximum measured concentration (Cmax) of BI 765049 after multiple administrations
Measured: up to 20 days
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after first administration
Measured: up to 4 days
Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ) after multiple administrations
Measured: up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start28 Mar 2025
- Primary completion8 Sep 2026
- Study completion8 Sep 2026
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 and part 2 run in parallel
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882746
- Sponsor's protocol ID
- 1454-0015
- Other IDs
- 2024-519301-36-00, U1111-1316-8363
- Status last verified
- Oct 2026
- First submitted
- 17 Mar 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06882746
- Acronym / sponsor ID
- 1454-0015
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 8 Sep 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 1 and part 2 run in parallel
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Administration Regimen A) | Experimental | Drug: BI 765049 |
| Part 2 (Administration Regimen B) | Experimental | Drug: BI 765049 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 765049BI 765049 | Drug | Part 1 (Administration Regimen A), Part 2 (Administration Regimen B) |
Primary outcome
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time frame: up to 36 months
6 secondary outcomes
Objective response (OR)
Time frame: up to 36 months
Occurrence of DLTs and adverse events during the entire treatment period
Time frame: up to 36 months
Maximum measured concentration (Cmax) of BI 765049 after first administration
Time frame: up to 4 days
Maximum measured concentration (Cmax) of BI 765049 after multiple administrations
Time frame: up to 20 days
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
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
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 765049 in people with Colorectal Carcinoma and Gastric Carcinoma, run by Boehringer Ingelheim at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period (time frame: up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.