SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET

Ki vehet részt

• They have signed the consent form before any study-related tests or procedures are done and are willing to follow all study requirements
• They are 18 years of age or older
• They have a confirmed diagnosis of an advanced or metastatic cancer that cannot be cured with surgery, radiation, or other treatments
• Phase 1: Non-squamous non-small cell lung cancer (ns-NSCLC)
• Phase 2: Non-squamous non-small cell lung cancer (ns-NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), or cholangiocarcinoma (bile duct cancer)
• Their cancer has worsened after previous treatments, or they cannot receive further standard treatments because of reasons such as side effects or medical conditions
• For lung cancer (ns-NSCLC): Previously treated with chemotherapy, immunotherapy, and targeted therapies if applicable
• For colorectal cancer (CRC): Previously treated with standard chemotherapy and other suitable targeted or immune therapies if specific genetic changes were present
• For head and neck cancer (HNSCC): Previously treated with platinum-based chemotherapy and immunotherapy
• For cholangiocarcinoma: Previously treated with at least one chemotherapy regimen
• The cancer must be c-MET positive, meaning laboratory testing of the tumor shows a moderate to high level of c-MET protein in at least half of the cancer cells
• At least one tumor can be measured on scans according to standard cancer assessment criteria
• The participant is generally well enough for daily activities, with an ECOG Performance Status of 0 or 1 (fully active or only restricted in strenuous activities)
• Important organs are functioning adequately, based on blood and laboratory test results, including:
• Normal heart rhythm measurement (QTc interval)
• Women who can become pregnant must have a negative pregnancy test during screening and again shortly before starting study treatment
• Women who can become pregnant must use an effective birth control method from the first dose of study treatment until 6 months after the last dose
• Sexually active men must use a barrier method of contraception (such as condoms) during the study and for about 3 months after the last dose. They must also not donate sperm during this period

Ki nem vehet részt

• People with previously treated brain metastases may still be eligible if they are stable, have no symptoms, and are not taking steroids for neurological problems
• They have previously received radioactive cancer treatments, such as radioembolization (for example, Y-90 treatment)
• They received anti-cancer treatment within the last 4 weeks before starting the study drug; They received an experimental (investigational) anti-cancer treatment within the last 4 weeks or within 5 half-lives of that treatment (whichever period is longer)
• They received radiation therapy too recently, including:; Radiation to a large area of bone marrow within 6 weeks before study treatment, or; Radiation to a specific area within 2 weeks before study treatment
• They had major surgery within the last 6 weeks or have not completely recovered from the surgery and its side effects
• They are pregnant or breastfeeding, or plan to become pregnant or donate eggs during the study or within 6 months after the last dose of the study drug
• Cancer has spread to the brain or spinal cord and has not been treated
• They have a serious medical or mental health condition that could make participation unsafe or affect the study results
• They are allergic to the study drug or any of its ingredients
• They still have significant side effects from previous cancer treatments; People may still be eligible if they have:; Hair loss of any severity,; Mild to moderate nerve damage (Grade 2),; Moderate fatigue (Grade 2),; Stable diabetes,; Well-controlled underactive or overactive thyroid disease
• They have a history of interstitial lung disease (a serious lung condition that causes scarring and inflammation of the lungs)
• They have serious heart disease, including:; Heart attack within the last 6 months,; Unstable chest pain (angina),; Moderate to severe heart failure,; Uncontrolled high blood pressure,; Uncontrolled abnormal heart rhythms,; Severe narrowing of the aortic heart valve
• They have an active infection that requires treatment, including:; HIV,; Hepatitis B,; Hepatitis C,; COVID-19 (SARS-CoV-2); However, some people with chronic HIV, hepatitis B, or hepatitis C may be allowed to participate if their infection is well controlled and approved by the study doctor
• They have had another type of active cancer within the last 3 years, apart from the cancer being studied; Some exceptions may be allowed if the other cancer is well controlled and does not require treatment during the study
• They are currently participating in another clinical trial that involves treatment or intervention