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

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Intervention Model Description
Phase 1A: sequential; Phase 1B and Phase 2: parallel
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
FMC-376 		Dose Escalation, Dose Expansion, and Cohort Expansion; Administered for 21-day cycle
  • Drug: FMC-376
    Oral Capsule

Recruiting Locations

University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center
La Jolla 5363943, California 5332921 92037
Contact:
Study Coordinator
858-822-5354
rrpatel@health.ucsd.edu

University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center
Orange 5379513, California 5332921 92868
Contact:
Research Manager
714-509-2922
joonsy@hs.uci.edu

University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco 5391959, California 5332921 94158
Contact:
Project Manager
418-969-0533
phu.lam@ucsf.edu

Florida Cancer Specialists and Research Institute
Lake Mary 4161373, Florida 4155751 32746
Contact:
Study Coordinator
407-804-6133
ajackson@flcancer.com

Northwest Cancer Centers
Dyer 4919820, Indiana 4921868 46311
Contact:
Study Coordinator
219-924-8178
karyn.burnworth@usoncology.com

The University of Kansas Cancer Center
Fairway 4271358, Kansas 4273857 66205
Contact:
Study Coordinator
913-945-7552
CTNurseNav@kumc.edu

Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
Contact:
Study Coordinator
877-338-7425
matthew_olszewski@dfci.harvard.edu

Karmanos Cancer Institute
Detroit 4990729, Michigan 5001836 48201
Contact:
Study Coordinator
313-576-9816
galiciv@karmanos.org

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Program Manager
267-414-6179
jennifer.louie2@pennmedicine.upenn.edu

The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Study Coordinator
888-513-6613
adeshmukh1@mdanderson.org

Community Clinical Trials
Kingwood 7534469, Texas 4736286 77339
Contact:
Site Research Staff
325-298-7478
kemi@communityclinicaltrials.com

South Texas Accelerated Research Therapeutics, LLC
San Antonio 4726206, Texas 4736286 78229
Contact:
Physician Referral Coordinator
210-593-5265
isabel.jimenez@startsa.com

UT Health San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Clinical Trials Specialist
210-450-5798
goodwine@uthscsa.edu

START Mountain Region
West Valley City 5784607, Utah 5549030 84119
Contact:
Director, Clinical Operation
801-907-4770
marie.asay@startthecure.com

Virginia Cancer Specialists
Fairfax 4758023, Virginia 6254928 22031
Contact:
Clinical Trials Nurse Navigator
703-636-1473
carrie.friedman@usoncology.com

More Details

Status
Recruiting
Sponsor
Frontier Medicines Corporation

Study Contact

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