Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06244771

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

Led by Frontier Medicines Corporation · Updated on 2026-03-18

403

Participants Needed

26

Research Sites

215 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 26 locations

1

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

La Jolla, California, United States, 92037

Actively Recruiting

2

University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center

Orange, California, United States, 92868

Completed

3

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

San Francisco, California, United States, 94158

Actively Recruiting

4

Florida Cancer Specialists and Research Institute

Lake Mary, Florida, United States, 32746

Completed

5

Northwest Cancer Centers

Dyer, Indiana, United States, 46311

Actively Recruiting

6

The University of Kansas Cancer Center

Fairway, Kansas, United States, 66205

Actively Recruiting

7

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

8

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

9

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

10

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

11

Community Clinical Trials

Kingwood, Texas, United States, 77339

Completed

12

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States, 78229

Actively Recruiting

13

UT Health San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

14

START Mountain Region

West Valley City, Utah, United States, 84119

Actively Recruiting

15

Virginia Cancer Specialists

Fairfax, Virginia, United States, 22031

Actively Recruiting

16

Macquarie University

Macquarie Park, New South Wales, Australia, 2109

Actively Recruiting

17

Tasman Health Care

Southport, Queensland, Australia, 4215

Actively Recruiting

18

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia, Australia, 5037

Actively Recruiting

19

GenesisCare North Adelaide

North Adelaide, South Australia, Australia, 5006

Actively Recruiting

20

Eastern Health - Box Hill Hospital

Box Hill, Victoria, Australia, 3128

Actively Recruiting

21

Linear Clinical Research Ltd

Nedlands, Western Australia, Australia, 6009

Actively Recruiting

22

Seoul National University Hospital

Seoul, Jongno-gu, South Korea, 03080

Actively Recruiting

23

Severance Hospital

Seoul, Seodaemun-gu, South Korea, 03722

Actively Recruiting

24

Korea University Anam Hospital

Seoul, Seongbuk-gu, South Korea, 02841

Actively Recruiting

25

Seoul National University Bundang Hospital

Gyeonggi-do, Seongnam-si, South Korea, 13620

Actively Recruiting

26

The Catholic University of Korea, St. Vincent's Hospital

Gyeonggi-do, Suwon-si, South Korea, 16247

Actively Recruiting

Loading map...

Research Team

M

Medical Lead

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here