An Open Label, Phase I Dose-finding Study of BI 765179 as Monotherapy and in Combination With Ezabenlimab (BI 754091) in Patients With Advanced Solid Cancers

  • End date
    Jul 1, 2025
  • participants needed
  • sponsor
    Boehringer Ingelheim
Updated on 27 October 2022
breast cancer
bone marrow procedure
advanced cancer
primary cancer


This study is open to adults with advanced cancer (solid tumors). People for whom previous treatment was not successful can take part in this study.

The purpose 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.

Each participant is put into one of two groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks.

BI 765179 and ezabenlimab 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 3 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.

Condition Neoplasms
Treatment ezabenlimab, BI 765179
Clinical Study IdentifierNCT04958239
SponsorBoehringer Ingelheim
Last Modified on27 October 2022


Yes No Not Sure

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
Hepatocellular carcinoma
Cutaneous squamous cell carcinoma
Pancreatic adenocarcinoma
Colorectal cancer
Malignant pleural mesothelioma
Cervical squamous cell cancer
Ovarian carcinoma
At least 18 years of age at the time of the consent or over the legal age of consent
Triple-negative breast cancer
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) 1.1
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)1 and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. These methods must be used during the study and for at least 6 months after the last dose of the study medication. A list of contraception methods meeting these criteria is provided in the patient information
Patients with brain metastases are eligible provided they meet all of the following
brain metastases have adequately been treated and are considered stable by the Investigator
radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 765179
patient is off steroids for at least 7 days (physiologic doses of steroids is permitted, if this was stable for the last 4 weeks)
the patient is off anti-epileptic drugs for at least 7 days
Back-fill cohorts only
Patient has agreed to and signed an informed consent (IC) form to provide mandatory pre-treatment and on-treatment fresh tumor biopsy
At least one lesion (separate from the evaluable target lesion outside of the CNS as defined per RECIST v1.1) that is accessible for mandatory paired pre and on-treatment biopsy

Exclusion Criteria

Currently enrolled in another investigational device or drug trial
Previous or concomitant malignancies other than the one treated in this trial within the last 2 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'
Previous treatment with agents targeting CD137
Known leptomeningeal disease or spinal cord compression due to disease
Anticoagulant treatment that cannot be safely interrupted if medically needed (e.g., biopsy) based on the opinion of the Investigator
Patient has a diagnosis of immunodeficiency
Persistent toxicity from previous treatments that has not resolved to ≤ Common terminology criteria for adverse events (CTCAE) Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy)
Patient with history of immunosuppressive medication within 14 days prior to the first dose of BI 765179. The following are exceptions to this criterion
Use of intranasal, inhaled, or topical corticosteroids, local steroid injections (e.g., intra-articular injections)
Physiological replacement dose of corticosteroids
Systemic corticosteroids at physiologic doses ≤10 mg/day (prednisone or equivalent)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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