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
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center
RECRUITING
La Jolla
University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center
RECRUITING
Orange
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
RECRUITING
San Francisco
Florida
Florida Cancer Specialists and Research Institute
RECRUITING
Lake Mary
Indiana
Northwest Cancer Centers
RECRUITING
Dyer
Kansas
The University of Kansas Cancer Center
RECRUITING
Fairway
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Community Clinical Trials
RECRUITING
Kingwood
South Texas Accelerated Research Therapeutics, LLC
RECRUITING
San Antonio
UT Health San Antonio
RECRUITING
San Antonio
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Other Locations
Australia
Eastern Health - Box Hill Hospital
NOT_YET_RECRUITING
Box Hill
Icon Cancer Centre Kurralta Park
NOT_YET_RECRUITING
Kurralta Park
Macquarie University
NOT_YET_RECRUITING
Macquarie Park
Linear Clinical Research Ltd
RECRUITING
Nedlands
GenesisCare North Adelaide
RECRUITING
North Adelaide
Tasman Health Care
RECRUITING
Southport
Contact Information
Primary
Medical Lead
clinicaltrials@frontiermeds.com
+1 (650) 457-1005
Time Frame
Start Date:2024-02-12
Estimated Completion Date:2028-04
Participants
Target number of participants:403
Treatments
Experimental: FMC-376
Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle