Clinical Research Directory

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 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 criteria: * 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 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 Phase 1b: * Histologically or cytologically confirmed diagnosis of metastatic or incurable, recurrent head and neck squamous cell carcinoma (HNSCC) * No prior systemic therapy administered in the metastatic or incurable, recurrent setting * Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx * 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 IC in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply Exclusion Criteria: Phase 1a * 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 * 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 has a diagnosis of immunodeficiency * 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) * Systemic corticosteroids at physiologic doses ≤10 mg/day (prednisone or equivalent) * Physiological replacement dose of corticosteroids Further exclusion criteria apply. Phase Ib * Disease suitable for local therapy administered with curative intent * Participants must not have a primary tumor site of nasopharynx or sino-nasal cancer or salivary gland cancers (any histology) * Currently enrolled in another investigational device or drug trial * Life expectancy of \<3 months and/or has rapidly progressing disease * Diagnosed and/or treated additional malignancy within 2 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or in situ breast cancers Further exclusion criteria apply