NCT06244771 A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
| NCT ID | NCT06244771 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Frontier Medicines Corporation |
| Condition | Advanced Solid Tumors With KRAS G12C Mutations |
| Study Type | INTERVENTIONAL |
| Enrollment | 403 participants |
| Start Date | 2024-02-12 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 403 participants in total. It began in 2024-02-12 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Medical Lead
STUDY DIRECTOR
Frontier Medicines Corporation
Frequently Asked Questions
Who can join the NCT06244771 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors With KRAS G12C Mutations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06244771 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06244771 currently recruiting?
Yes, NCT06244771 is actively recruiting participants. Contact the research team at clinicaltrials@frontiermeds.com for enrollment information.
Where is the NCT06244771 trial being conducted?
This trial is being conducted at La Jolla, United States, Orange, United States, San Francisco, United States, Lake Mary, United States and 11 additional locations.
Who is sponsoring the NCT06244771 clinical trial?
NCT06244771 is sponsored by Frontier Medicines Corporation. The principal investigator is Medical Lead at Frontier Medicines Corporation. The trial plans to enroll 403 participants.