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An open label, phase I PET imaging study to investigate the bio- distribution and tumor uptake of [89Zr]Zr-BI 765179 as monotherapy and in combination with ezabenlimab (BI 754091) in patients with advanced solid cancers

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NB; bij arm D (toegankelijk voor NSCLC), is ook een biopteerbare laesie nodig en mogen patiënten geen splenectomie hebben gehad.

No. of patients

0 / 27


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


This is an open label, non-randomized bio-distribution trial, using a staggered approach:

  • Part 1: dosimetry and feasibility assessment of [89Zr]Zr-BI 765179 PET / CT
  • Part 2: assessment of tumor uptake of [89Zr]Zr-BI 765179

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


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

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