Study on [225Ac]Ac-FL-261 for Patients with Solid Tumors with High c-MET Levels

Inclusion Criteria

• Must sign a consent form and agree to follow study requirements.
• Must be 18 years or older.
• Must have advanced or metastatic cancer that cannot be cured with standard treatments.
• For Phase 1: Must have non-squamous non-small cell lung cancer (ns-NSCLC).
• For Phase 2: Must have ns-NSCLC, colorectal cancer, head and neck cancer, or cholangiocarcinoma.
• Cancer must have worsened after previous treatments or cannot receive further standard treatments.
• For lung cancer: Must have had chemotherapy, immunotherapy, and targeted therapies if applicable.
• For colorectal cancer: Must have had standard chemotherapy and other therapies if specific genetic changes were present.
• For head and neck cancer: Must have had platinum-based chemotherapy and immunotherapy.
• For cholangiocarcinoma: Must have had at least one chemotherapy regimen.
• Cancer must be c-MET positive, meaning high levels of c-MET protein in at least half of the cancer cells.
• Must have at least one tumor that can be measured on scans.
• Must be well enough for daily activities, with an ECOG Performance Status of 0 or 1.
• Must have adequate organ function based on blood and lab tests.
• Women who can become pregnant must have a negative pregnancy test and use effective birth control during and after the study.
• Sexually active men must use a barrier method of contraception and not donate sperm during and after the study.

Exclusion Criteria

• Cancer has spread to the brain or spinal cord and has not been treated.
• Serious medical or mental health conditions that could make participation unsafe.
• Previously received radioactive cancer treatments.
• Received anti-cancer treatment within the last 4 weeks before starting the study drug.
• Received an experimental treatment within the last 4 weeks or within 5 half-lives of that treatment.
• Received recent radiation therapy, including:
  • Large area of bone marrow within 6 weeks before study treatment.
  • Specific area within 2 weeks before study treatment.
• Had major surgery within the last 6 weeks or have not recovered from surgery.
• Allergic to the study drug or its ingredients.
• Participating in another clinical trial involving treatment.
• Significant side effects from previous cancer treatments, except:
  • Hair loss,
  • Mild to moderate nerve damage,
  • Moderate fatigue,
  • Stable diabetes,
  • Well-controlled thyroid disease.
• History of interstitial lung disease.
• Serious heart disease, including:
  • Recent heart attack,
  • Unstable chest pain,
  • Moderate to severe heart failure,
  • Uncontrolled high blood pressure,
  • Uncontrolled abnormal heart rhythms,
  • Severe narrowing of the aortic valve.
• Active infection requiring treatment, including:
  • HIV,
  • Hepatitis B,
  • Hepatitis C,
  • COVID-19.
• Another active cancer within the last 3 years, except well-controlled cases.
• Pregnant or breastfeeding, or planning to become pregnant or donate eggs during or after the study.