Study on Bemarituzumab for Solid Tumors with High FGFR2b Levels

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of certain types of cancer that have not responded to or have returned after standard treatments. This includes:
  • Head and neck cancer: at least one prior treatment
  • Triple-negative breast cancer: at least two prior treatments
  • Intrahepatic cholangiocarcinoma: at least one prior treatment
  • Lung adenocarcinoma: must have had platinum-based chemotherapy, a checkpoint inhibitor, and targeted therapy
  • Platinum-resistant ovarian cancer: at least one prior treatment
  • Endometrial cancer: at least one prior treatment
  • Cervical cancer: at least one prior treatment
  • Other solid tumors: at least one prior treatment
• Cancer that cannot be surgically removed, is locally advanced, or has spread to other parts of the body.
• Tumor must have high levels of FGFR2b protein, confirmed by a specific test.
• Must have measurable disease according to standard criteria.
• Must be in good overall health with a performance status of 0 or 1.
• Must have adequate organ function as per study requirements.

Exclusion Criteria

• Have untreated or symptomatic cancer spread to the brain or spinal fluid.
• Have certain types of cancer, including primary brain tumors, squamous non-small cell lung cancer, stomach cancer, or gastroesophageal junction cancer.
• Have significant heart problems, such as recent heart attack, severe heart failure, or uncontrolled high blood pressure.
• Have a history of eye diseases requiring long-term steroid use.
• Have ongoing or recent eye problems, such as corneal defects or recent eye surgery.
• Are unwilling to avoid wearing contact lenses during and for 100 days after treatment.
• Have previously been treated with drugs targeting the FGF/FGFR pathway, unless it was a standard treatment for their cancer.