Full-Life Technologies UK Limited
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.
Phase 1: Dose Escalation \[225Ac\]Ac-FL-261 will be administered at increasing doses in participants with non-squamous non-small cell lung cancer (ns-NSCLC) to identify the maximum tolerated dose (MTD) based on a BOIN design. Phase 1 - Dose Optimization After Dose Escalation is complete, 2 treatment regimens will be compared to select the optimal treatment regimen (OTR) between them. Phase2 Participants with ns-NSCLC, colorectal cancer, head and neck cancer and cholangiocarcinoma will be enrolled into separate cohorts to estimate the efficacy of \[225Ac\]Ac-FL-261 at the OTR in each indic…
Inclusion Criteria: * 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 worsen…
Dose escalation per BOIN design to determine MTD.
Two candidate dosing regimens, randomized 1:1 (30 participants per arm)
* Non-squamous non-small cell lung cancer (NSCLC) * Colorectal cancer (CRC) * Head and neck squamous cell carcinoma (HNSCC) * Cholangiocarcinoma
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