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New treatment option for Colorectal Carcinoma
Official title A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas
ClinicalTrials.gov ID: NCT06882746
What this study is testing
What is BI 765049?
BI 765049 is an investigational medicine, given as an once-daily, being studied as a potential treatment for colorectal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For all patients, signed and dated informed consent form (ICF)2/main ICF describing the study in accordance with International Council on...
- 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...
- In US: Patients with a histologically or cytologically confirmed diagnosis of colorectal carcinoma (CRC), gastric carcinoma (GC), or pancreatic...
- In Europe: Patients with a histologically or cytologically confirmed diagnosis of CRC.
- Patients with advanced, unresectable, and/or metastatic disease. Further apply.
You likely can't join if
- 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...
- 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"
See the full eligibility 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...
- 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 apply.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Atlanta, Georgia, United States
- Hackensack, New Jersey, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Atlanta, Georgia, United States; Hackensack, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.