RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Phase 1/2 Dose Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRAS G12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors

Quick Facts

Study Start:2024-02-12

Study Completion:2028-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06244771

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Andrew Krivoshik, MD, PhD

CONTACT

+1 (650) 457-1005

andrew.krivoshik@frontiermeds.com

Principal Investigator

Andrew Krivoshik, MD, PhD

STUDY_DIRECTOR

Frontier Medicines Corporation

Study Locations (Sites)

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

Orange, California, 92868

United States

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

San Francisco, California, 94158

United States

Florida Cancer Specialists and Research Institute

Lake Mary, Florida, 32746

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, 37203

United States

Community Clinical Trials

Kingwood, Texas, 77339

United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229

United States

START Mountain Region

West Valley City, Utah, 84119

United States

Virginia Cancer Specialists

Fairfax, Virginia, 22031

United States

Collaborators and Investigators

Sponsor: Frontier Medicines Corporation

Andrew Krivoshik, MD, PhD, STUDY_DIRECTOR, Frontier Medicines Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12

Study Completion Date2028-04

Study Record Updates

Study Start Date2024-02-12

Study Completion Date2028-04

Terms related to this study

Additional Relevant MeSH Terms

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