SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFull-Life Technologies UK Limited
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Cancer has spread to the brain or spinal cord and has not been treated.
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 a serious medical or mental health condition that could make participation unsafe or affect the study results.
They have previously received radioactive cancer treatments, such as radioembolization (for example, Y-90 treatment).
Trial design
Design model
Sequential
Treatments tested in this trial
[225Ac]Ac-FL-261
DrugDose escalation per BOIN design to determine MTD.
[225Ac]Ac-FL-261
DrugTwo candidate dosing regimens, randomized 1:1 (30 participants per arm)
[225Ac]Ac-FL-261
Drug* Non-squamous non-small cell lung cancer (NSCLC) * Colorectal cancer (CRC) * Head and neck squamous cell carcinoma (HNSCC) * Cholangiocarcinoma
Treatment groups
208 Participants
are divided into 3 treatment groupsGroup A: Phase 1 - Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1 - Dose OptimizationExperimental treatment 1 intervention
Group C: Phase 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1 Dose Escalation: Incidence of Dose-Limiting Toxicities (DLTs)
Time frame
Until 28 days after the first injection of [225Ac]Ac-FL-261]2
2. Phase 1 Dose Escalation and Phase 1 Dose Optimization: Type, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0
Time frame
From ICF signature and up to 35 days after the last dose of study treatment for all AEs/SAEs. Thereafter, only AEs of special interest (AESIs) and related SAEs will be reported (up to 5 years)3
Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame
Every 6 weeks for 24 weeks, then every 12 weeks until disease progression (up to 5 years)Secondary outcomes
1
Phase 1 and Phase 2: Duration of response (DoR)
Time frame
Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)2
Phase 1 and Phase 2: Disease control rate (DCR)
Time frame
Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)]3
Phase 1 and Phase 2: Progression-free survival (PFS) by RECIST v1.1
Time frame
Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)4
Phase 1 and Phase 2: Overall survival (OS)
Time frame
Every 6 weeks for 24 weeks, then every 12 weeks, until disease progression (up to 5 years)Sponsors and contacts
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Source ClinicalTrials.gov