Clinical trial NCT06244771: A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
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
Lead sponsor: Frontier Medicines Corporation
Sponsor class: INDUSTRY
First posted: 2024-02-06
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Phase 1A: sequential; Phase 1B and Phase 2: parallel
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Dose Limiting Toxicities
timeFrame: Up to 21 Days
measure: Adverse Events (AEs)
timeFrame: Approximately 24 Months
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of FMC-376
timeFrame: Approximately 24 Months
measure: Time to Reach Maximum Blood Concentration (Tmax) of FMC-376
timeFrame: Approximately 24 Months
measure: Minimum Observed Plasma Concentration (Cmin) of FMC-376
timeFrame: Approximately 24 Months
measure: Elimination Half-life (t1/2) of FMC-376
timeFrame: Approximately 24 Months
measure: Area Under Blood Concentration-Time Curve (AUC) of FMC-376
timeFrame: Approximately 24 Months
measure: Volume of Distribution (Vd) of FMC-376
timeFrame: Approximately 24 Months
measure: Clearance (CL) of FMC-376 from Blood Plasma
timeFrame: Approximately 24 Months
measure: Overall Response Rate (ORR)
timeFrame: Approximately 24 Months
measure: Duration of Response (DOR)
timeFrame: Approximately 24 Months
measure: Disease Control Rate (DCR)
timeFrame: Approximately 24 Months
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 24 Months
measure: Overall Survival (OS)
timeFrame: Approximately 24 Months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center
state: California
city: Orange
country: United States
facility: University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
state: California
city: Lake Mary
country: United States
facility: Florida Cancer Specialists and Research Institute
state: Florida
city: Dyer
country: United States
facility: Northwest Cancer Centers
state: Indiana
city: Fairway
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute Oncology Partners
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Kingwood
country: United States
facility: Community Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC
state: Texas
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
city: West Valley City
country: United States
facility: START Mountain Region
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
Study officials:
affiliation: Frontier Medicines Corporation
name: Medical Lead
role: STUDY_DIRECTOR
References: