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

Phase 2RecruitingNCT06244771

Frontier Medicines Corporation403 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

403

Conditions

Advanced Solid Tumors With KRAS G12C Mutations Solid Tumor, Adult Unresectable Solid Tumor Metastatic Solid Tumor Non Small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (26)

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

La Jolla, California, United States

RECRUITING

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

Orange, California, United States

COMPLETED

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

San Francisco, California, United States

RECRUITING

Florida Cancer Specialists and Research Institute

Lake Mary, Florida, United States

Outcomes

Primary Outcomes

Dose Limiting Toxicities

Number of participants with Dose Limiting Toxicities (DLTs)

Time frame: Up to 21 Days

Adverse Events (AEs)

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