A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Can… (NCT04958239) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer
United States, Australia, Belgium151 participantsStarted 2021-10-18
Plain-language summary
This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer.
In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein.
BI 765179, ezabenlimab, and pembrolizumab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time.
Participants can stay in the study up to 2 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All cohorts:
* Patients with locally advanced, unresectable or metastatic solid tumors who are either refractory after standard therapy for the disease or for whom standard therapy is not appropriate
* Tumor with expected high expression of Fibroblast activation protein (FAP) of the following histologies:
* Non-small cell lung carcinoma (NSCLC)
* Gastric cancer
* Esophageal adenocarcinoma or squamous cell carcinoma
* Urothelial bladder carcinoma
* Head and neck squamous cell carcinoma
* Cutaneous malignant melanoma
* Cutaneous squamous cell carcinoma
* Hepatocellular carcinoma
* Pancreatic adenocarcinoma
* Colorectal cancer
* Malignant pleural mesothelioma
* Cervical squamous cell cancer
* Ovarian carcinoma
* Triple-negative breast cancer
* At least 18 years of age at the time of the consent or over the legal age of consent in countries where that is greater than 18 years
* Signed and dated, written informed consent (IC) in accordance with ICH-GCP and local legislation prior to admission to the trial
* At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response evaluation criteria in solid tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate liver, bone marrow and renal organ function
* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective meth…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1a: Maximum Tolerated Dose (MTD)
Timeframe: Up to Day 21 (end of Cycle 1)
2
Phase 1a: Occurrence of Dose Limiting Toxicities (DLTs) in the MTD evaluation period