CD137/FAP

Key outcome parameters

The intra-tumor accumulation of [89Zr]Zr-BI 765179 at baseline and its change upon treatment with varying doses of BI 765179

Intervention

Each patient will undergo 2 phases of PET imaging assessments:

• Baseline assessment at Cycle 1
• On-treatment assessment at Cycle 2: after study treatment

Key inclusion criteria

Inclusion criteria

• Tumor with expected high expression of FAP of the following histologies:
  •  Non small cell lung carcinoma
  • Gastric cancer
  • Esophageal adenocarcinoma or squamous cell carcinoma
  • Urothelial bladder carcinoma
  • Oral squamous cell cancer
  • Cutaneous malignant melanoma
  • Hepatocellular carcinoma
  • Pancreatic adenocarcinoma
  • Colorectal cancer
  • Malignant pleural mesothelioma
  • Cervical squamous cell cancer
  • Ovarian carcinoma
• Adequate liver, bone marrow and renal organ function
• At least one measurable lesion outside of CNS as defined per RECIST 1.1.
• Patients with brain metastases are eligible provided they meet 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 are permitted, if this was stable for
    the last 4 weeks), and the patient is off anti-epileptic
    drugs for at least 7 days.
• Patient must have at least one PET imageable and evaluable
  tumor lesion with a diameter of at least 20 mm

Key exclusion criteria

Exclusion criteria

• 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 cervi
  • 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
• Anticoagulant treatment that cannot be safely interrupted based on opinion of the Investigator if medically needed (e.g. biopsy)
• Persistent toxicity from previous treatments that has not resolved to ≤ 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
• Prior anti-cancer therapy: Patients who have been treated with any other anticancer drug within 3 weeks or within 5 half-life periods (whichever is shorter) prior to first administration of BI 765179
• Patients who have been treated with extensive field radiotherapy including whole brain irradiation within 2 weeks prior to first administration of BI 765179
• Major injuries or surgery performed within 28 days prior to first dose of BI 765179.
• Patients with a previous or planned coronary revascularization (such as stent placement or heart bypass)
• Any type of chronic non-healing wound/injury
• Patient with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment (i.e. corticosteroids or immunosuppressive drugs)
• Patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that do not require systemic therapy, patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen may be included if in the opinion of the Investigator it is appropriate and safe to do so
• Pulmonary-, renal- or liver fibrosis
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial or within 6 months after the last dose of trial treatment