Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing FMC-376 in advanced solid tumours carrying a KRAS G12C mutation, using increasing doses followed by expansion cohorts. The record does not explain how FMC-376 is expected to act on the cancer.
The main aim is to find doses that participants can tolerate, measured by dose-limiting toxicities, before examining the drug in larger groups. This is not a comparison with standard treatment and does not yet test whether people live longer or go longer before the cancer grows.
Worth knowing: Despite the phase 2 label, the study includes dose escalation and expansion, and its main measure is safety rather than treatment benefit.
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 | NCT06244771 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | open label |
| Taking part | 403 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Frontier Medicines Corporation |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug FMC-376
What it is measuring
Dose Limiting Toxicities
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
The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- (K/N)RAS mutated
- G12C
- Metastatic
- Locally advanced
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
- Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
- Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematological, renal, and hepatic function
- Agrees not to participate in another interventional study while receiving study drug
Exclusion Criteria
- Leptomeningeal disease or carcinomatous meningitis
- Clinically significant toxicity resulting from prior cancer therapies
- Known or suspected hypersensitivity to FMC-376 or any components of the study drug
- Condition that would interfere with study drug absorption
- Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data
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 26 sites. Listed in: Australia, South Korea, United States.
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 NCT06244771, registered by Frontier Medicines Corporation 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.