Tests FMC-376 alone and with pembrolizumab in advanced KRAS G12C tumors
Tests FMC-376, alone or with pembrolizumab, in adults with advanced KRAS G12C tumors.
Plain-language title generated from the registry record
Registry title: A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
Key facts
- Where
- Box Hill, Kurralta Park, Macquarie Park, Nedlands, North Adelaide, and Southport, AustraliaSee the 6 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic solid tumors that carry a KRAS G12C mutation, including non-small cell lung cancer.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Locally advanced tumor that cannot be removed by surgery, or metastatic solid tumor, confirmed under the microscope. Lung cancer patients may be in the first-line advanced or metastatic setting.
- Earlier treatment
- Must have had standard therapy and progressed or could not tolerate it, or standard therapy is considered inappropriate, or an investigational agent is considered standard of care. First-line lung cancer patients must have refused standard therapy or it was considered inappropriate.
- Biomarker or test result
- KRAS G12C mutation in the tumor
Main reasons for not taking part
- Leptomeningeal disease or carcinomatous meningitis
- Clinically significant toxicity from prior cancer therapies
- Known or suspected hypersensitivity to FMC-376 or its components
- Condition that would interfere with study drug absorption
- For the pembrolizumab combination: autoimmune disease, immune-related adverse events or hepatitis, severe hypersensitivity (≥ Grade 3) to pembrolizumab, radiation-related toxicities, or non-infectious pneumonitis
Read by machine on 9 November 2026.
Where in Australia
- Eastern Health - Box Hill HospitalBox Hill, AustraliaNo longer taking part
- Icon Cancer Centre Kurralta ParkKurralta Park, AustraliaTaking people
- Macquarie UniversityMacquarie Park, AustraliaTaking people
- Linear Clinical Research LtdNedlands, AustraliaTaking people
- GenesisCare North AdelaideNorth Adelaide, AustraliaNo longer taking part
- Tasman Health CareSouthport, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Frontier Medicines Corporation
- Trial code
- NCT06244771
- Record updated
- 19 October 2026
- Original description
The goal of this clinical trial is to evaluate FMC-376 monotherapy and in combination with pembrolizumab 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.Read full original descriptionShow less
An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 Monotherapy and in Combination With Pembrolizumab in Participants With KRAS G12C Mutated Advanced Solid Tumors
The goal of this clinical trial is to evaluate FMC-376 monotherapy and in combination with pembrolizumab 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.
Inclusion: 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; NSCLC Participants (in the first-line advanced or metastatic setting who refused standard therapy or standard therapy was considered inappropriate); 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; For patients receiving FMC-376 in combination with pembrolizumab: No history of autoimmune disease, and no history of immune-related adverse events or hepatitis.
Exclusion: For patients receiving FMC-376 in combination with pembrolizumab: Has severe hypersensitivity (≥ Grade 3) to pembrolizumab, history of radiation-related toxicities, or history of non-infectious pneumonitis; 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.