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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.