OncoMatch/Clinical Trials/NCT07873450
SumMET: Study of [225Ac]Ac-FL-261 in Participants With Solid Tumors Overexpressing c-MET
Official title: 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
Is NCT07873450 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies [225Ac]Ac-FL-261 for solid tumor.
Treatment: [225Ac]Ac-FL-261 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Colorectal Cancer
Head and Neck Squamous Cell Carcinoma
Cholangiocarcinoma
Biomarker criteria
Required: MET overexpression (moderate to high level in at least half of the cancer cells)
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.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — NSCLC
For lung cancer (ns-NSCLC): Previously treated with chemotherapy, immunotherapy, and targeted therapies if applicable.
Must have received: immunotherapy — NSCLC
For lung cancer (ns-NSCLC): Previously treated with chemotherapy, immunotherapy, and targeted therapies if applicable.
Must have received: targeted therapy — NSCLC
For lung cancer (ns-NSCLC): Previously treated with chemotherapy, immunotherapy, and targeted therapies if applicable.
Must have received: chemotherapy — Colorectal Carcinoma
For colorectal cancer (CRC): Previously treated with standard chemotherapy and other suitable targeted or immune therapies if specific genetic changes were present.
Must have received: targeted therapy — Colorectal Carcinoma
For colorectal cancer (CRC): Previously treated with standard chemotherapy and other suitable targeted or immune therapies if specific genetic changes were present.
Must have received: immunotherapy — Colorectal Carcinoma
For colorectal cancer (CRC): Previously treated with standard chemotherapy and other suitable targeted or immune therapies if specific genetic changes were present.
Must have received: platinum-based chemotherapy — Head and Neck Squamous Cell Carcinoma
For head and neck cancer (HNSCC): Previously treated with platinum-based chemotherapy and immunotherapy.
Must have received: immunotherapy — Head and Neck Squamous Cell Carcinoma
For head and neck cancer (HNSCC): Previously treated with platinum-based chemotherapy and immunotherapy.
Must have received: chemotherapy — Cholangiocarcinoma
For cholangiocarcinoma: Previously treated with at least one chemotherapy regimen.
Cannot have received: radioactive cancer treatment
They have previously received radioactive cancer treatments, such as radioembolization (for example, Y-90 treatment).
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
Normal heart rhythm measurement (QTc interval)
Important organs are functioning adequately, based on blood and laboratory test results, including: Normal heart rhythm measurement (QTc interval).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07873450 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radioactive cancer treatment disqualifies patients from enrollment.
Does this trial require MET?
Yes, MET overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify