Clinical Trial · NCT07873450

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 1/2

Contacts

Full-Life Technologies (CONTACT)

clinicaltrials@t-full.com

617-939-7858

ClinicalTrials.gov

NCT07873450

Drug / Compound

FL-261

Isotope(s):

Target(s):

c-MET receptor tyrosine kinase

Ligand Class: Small Molecules

Eligibility

Inclusion

At least one tumor can be measured on scans according to standard cancer assessment criteria.
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.
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).
Phase 1: Non-squamous non-small cell lung cancer (ns-NSCLC).
Their cancer has worsened after previous treatments, or they cannot receive further standard treatments because of reasons such as side effects or medical conditions.
Normal heart rhythm measurement (QTc interval).
For colorectal cancer (CRC): Previously treated with standard chemotherapy and other suitable targeted or immune therapies if specific genetic changes were present.
They have signed the consent form before any study-related tests or procedures are done and are willing to follow all study requirements.
Important organs are functioning adequately, based on blood and laboratory test results, including:
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).
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.
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.
They have a confirmed diagnosis of an advanced or metastatic cancer that cannot be cured with surgery, radiation, or other treatments.
For lung cancer (ns-NSCLC): Previously treated with chemotherapy, immunotherapy, and targeted therapies if applicable.
Women who can become pregnant must have a negative pregnancy test during screening and again shortly before starting study treatment.

Exclusion

HIV,
They have a history of interstitial lung disease (a serious lung condition that causes scarring and inflammation of the lungs).
They still have significant side effects from previous cancer treatments.
They have had another type of active cancer within the last 3 years, apart from the cancer being studied.
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.
Heart attack within the last 6 months,
Radiation to a large area of bone marrow within 6 weeks before study treatment, or
They are allergic to the study drug or any of its ingredients.
Mild to moderate nerve damage (Grade 2),
Moderate fatigue (Grade 2),
People may still be eligible if they have:
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).
Uncontrolled high blood pressure,
Hepatitis B,
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.
Hepatitis C,
Uncontrolled abnormal heart rhythms,
Hair loss of any severity,
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 an active infection that requires treatment, including:
Moderate to severe heart failure,
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).
Well-controlled underactive or overactive thyroid disease.
They had major surgery within the last 6 weeks or have not completely recovered from the surgery and its side effects.
Stable diabetes,
Unstable chest pain (angina),
They are currently participating in another clinical trial that involves treatment or intervention.
Some exceptions may be allowed if the other cancer is well controlled and does not require treatment during the study.
They have serious heart disease, including:
They received radiation therapy too recently, including:
Severe narrowing of the aortic heart valve.
Radiation to a specific area within 2 weeks before study treatment.