Recruiting nowPhase 2Randomised
What this trial is trying to do
The researchers are testing [225Ac]Ac-FL-261, a radioligand therapy that is designed to bind c-MET, a protein overproduced by some tumours, and deliver radioactive particles directly to cancer cells. The trial will first find a tolerable dose, then compare two dosing schedules before testing the selected dose in different tumour types.
The idea is that targeting c-MET could concentrate radiation in cancer cells while limiting exposure to other tissues, and that choosing the right dose and schedule might improve tumour control or tolerability. The trial measures safety first, including dose-limiting side effects, and later will assess activity in tumour-specific groups rather than compare the treatment with standard care.
Worth knowing: This is a first-in-human Phase 1/2 trial, so the main early question is safety and the appropriate dose, not whether the treatment improves survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07873450 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 208 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Full-Life Technologies UK Limited |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug [225Ac]Ac-FL-261
What it is measuring
Phase 1 Dose Escalation: Incidence of Dose-Limiting Toxicities (DLTs)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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 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 on…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: Australia.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07873450, registered by Full-Life Technologies UK Limited on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.