Recruiting

Phase 1

Phase 2

FMC-376A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors

Sponsor:

Frontier Medicines Corporation

Code:

NCT06244771

Conditions

Advanced Solid Tumors With KRAS G12C Mutations

Solid Tumor, Adult

Unresectable Solid Tumor

Metastatic Solid Tumor

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FMC-376

Study Details

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.

Conditions

Advanced Solid Tumors With KRAS G12C Mutations

Solid Tumor, Adult

Unresectable Solid Tumor

Metastatic Solid Tumor

Non Small Cell Lung Cancer

Study ID

NCT06244771

Start date

Feb 12, 2024

Status verified date

Mar, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

403 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FMC-376

Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle

Interventions

FMC-376

Oral Capsule Daily

Primary outcome measure

Dose Limiting Toxicities [ Time Frame: Up to 21 Days ]
Adverse Events (AEs) [ Time Frame: Approximately 24 Months ]

Central Contacts and Locations

Central contacts

Medical Lead

+1 (650) 457-1005 clinicaltrials@frontiermeds.com

Locations

University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Study Coordinator

858-822-5354 rrpatel@health.ucsd.edu

University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94158

Contacts

Project Manager

418-969-0533 phu.lam@ucsf.edu

Northwest Cancer Centers

Recruiting

Dyer, Indiana, United States, 46311

Contacts

Study Coordinator

219-924-8178 karyn.burnworth@usoncology.com

The University of Kansas Cancer Center

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Study Coordinator

913-945-7552 CTNurseNav@kumc.edu

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

877-338-7425 matthew_olszewski@dfci.harvard.edu

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Study Coordinator

313-576-9816 galiciv@karmanos.org

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Program Manager

267-414-6179 jennifer.louie2@pennmedicine.upenn.edu

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

888-513-6613 adeshmukh1@mdanderson.org

South Texas Accelerated Research Therapeutics, LLC

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Physician Referral Coordinator

210-593-5265 isabel.jimenez@startsa.com

UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Clinical Trials Specialist

210-450-5798 goodwine@uthscsa.edu

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

Contacts

Director, Clinical Operation

801-907-4770 marie.asay@startthecure.com

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Clinical Trials Nurse Navigator

703-636-1473 carrie.friedman@usoncology.com

More Information

Sponsor

Frontier Medicines Corporation

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

Lung Cancer
KRAS
G12C

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Frontier Medicines Corporation on 2026-03-18.