Trial Title:
A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
NCT ID:
NCT06244771
Condition:
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
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
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)
Intervention:
Intervention type:
Drug
Intervention name:
FMC-376
Description:
Oral Capsule
Arm group label:
FMC-376
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Contact:
Last name:
Project Manager
Phone:
418-969-0533
Email:
alison.yip@ucsf.edu
Facility:
Name:
Florida Cancer Specialists and Research Institute
Address:
City:
Lake Mary
Zip:
32746
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
407-804-6133
Email:
ajackson@flcancer.com
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
313-576-9816
Email:
galiciv@karmanos.org
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Program Manager
Phone:
267-414-6179
Email:
jennifer.louie2@pennmedicine.upenn.edu
Facility:
Name:
Sarah Cannon Research Institute Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator, Research Operations
Phone:
615-329-7274
Email:
alydia.miller@scri.com
Facility:
Name:
South Texas Accelerated Research Therapeutics, LLC
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Physician Referral Coordinator
Phone:
210-593-5265
Email:
isabel.jimenez@startsa.com
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Contact:
Last name:
Director, Clinical Operation
Phone:
801-907-4770
Email:
marie.asay@startthecure.com
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Nurse Navigator
Phone:
703-636-1473
Email:
carrie.friedman@usoncology.com
Start date:
February 12, 2024
Completion date:
April 2028
Lead sponsor:
Agency:
Frontier Medicines Corporation
Agency class:
Industry
Source:
Frontier Medicines Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06244771
