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

NCT06244771 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: FMC-376-CL101
• Study Type: interventional
• Target: 403
• Locations: 3 countries
• Sites: 26

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; Colorectal Cancer; KRAS G12C; Pancreatic Cancer

Keywords

Lung Cancer; KRAS; G12C

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicities

  Number of participants with Dose Limiting Toxicities (DLTs)

  Up to 21 Days

• Adverse Events (AEs)

  Number of participants with treatment-emergent adverse events (TEAEs)

  Approximately 24 Months

Secondary Outcomes (12)

• Maximum Observed Plasma Concentration (Cmax) of FMC-376

  Approximately 24 Months

• Time to Reach Maximum Blood Concentration (Tmax) of FMC-376

  Approximately 24 Months

• Minimum Observed Plasma Concentration (Cmin) of FMC-376

  Approximately 24 Months

• Elimination Half-life (t1/2) of FMC-376

  Approximately 24 Months

• Area Under Blood Concentration-Time Curve (AUC) of FMC-376

  Approximately 24 Months

Study Arms (1)

FMC-376

EXPERIMENTAL

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

Drug: FMC-376

Interventions

FMC-376 DRUG

Oral Capsule Daily

FMC-376

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frontier Medicines Corporation: lead

Study Sites (26)

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

La Jolla, California, 92037, United States

RECRUITING

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

Orange, California, 92868, United States

COMPLETED

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

San Francisco, California, 94158, United States

RECRUITING

Florida Cancer Specialists and Research Institute

Lake Mary, Florida, 32746, United States

COMPLETED

Northwest Cancer Centers

Dyer, Indiana, 46311, United States

RECRUITING

The University of Kansas Cancer Center

Fairway, Kansas, 66205, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Community Clinical Trials

Kingwood, Texas, 77339, United States

COMPLETED

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229, United States

RECRUITING

UT Health San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Macquarie University

Macquarie Park, New South Wales, 2109, Australia

RECRUITING

Tasman Health Care

Southport, Queensland, 4215, Australia

RECRUITING

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia, 5037, Australia

RECRUITING

GenesisCare North Adelaide

North Adelaide, South Australia, 5006, Australia

RECRUITING

Eastern Health - Box Hill Hospital

Box Hill, Victoria, 3128, Australia

RECRUITING

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

RECRUITING

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

RECRUITING

Seoul National University Bundang Hospital

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

RECRUITING

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

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

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Pancreatic Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Medical Lead

  Frontier Medicines Corporation

  STUDY DIRECTOR

Central Study Contacts

Medical Lead

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1A: sequential; Phase 1B and Phase 2: parallel

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 6, 2024
• Study Start: February 12, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); AU (6); KR (5)