Tests a radioactive targeted drug in solid tumors with c-MET

Trial details

Who runs it

Full-Life Technologies UK Limited

Trial code

NCT07873450

Record updated

29 October 2026

Original description

This is a first-in-human, multicenter, open-label Phase 1/2 study designed to evaluate the safety, efficacy, and tolerability of [225Ac]Ac-FL-261, a targeted radioligand therapy directed at c-MET, in participants with advanced or metastatic solid tumors. Phase 1 will identify the recommended dose through dose escalation, followed by a randomized comparison of two candidate dosing regimens (dose optimization). In Phase 2, the selected dose will be tested in independent cohorts by tumor type.Read full original descriptionShow less

A First-in-Human Phase 1/2 Dose Escalation and Treatment Optimization Study Evaluating Safety, Tolerability, and Preliminary Efficacy of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET

This is a first-in-human, multicenter, open-label Phase 1/2 study designed to evaluate the safety, efficacy, and tolerability of [225Ac]Ac-FL-261, a targeted radioligand therapy directed at c-MET, in participants with advanced or metastatic solid tumors. Phase 1 will identify the recommended dose through dose escalation, followed by a randomized comparison of two candidate dosing regimens (dose optimization). In Phase 2, the selected dose will be tested in independent cohorts by tumor type.

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT07873450