A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoehringer Ingelheim
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Effectively treated non-melanoma skin cancers
Effectively treated carcinoma in situ of the cervix
Effectively treated ductal carcinoma in situ
Trial design
Design model
Parallel
Treatments tested in this trial
BI 765049
DrugBI 765049
Treatment groups
135 Participants
are divided into 2 treatment groupsGroup A: Part 1 (Administration Regimen A)Experimental treatment 1 intervention
Group B: Part 2 (Administration Regimen B)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
Time frame
up to 36 monthsSecondary outcomes
1
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.
Time frame
up to 36 months2
Occurrence of DLTs and adverse events during the entire treatment period
Time frame
up to 36 months3
Maximum measured concentration (Cmax) of BI 765049 after first administration
Time frame
up to 4 days4
Maximum measured concentration (Cmax) of BI 765049 after multiple administrations
Time frame
up to 20 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov