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

Colorectal Cancer Clinical Trial

— PROSPER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244771
• Other study ID #: FMC-376-CL101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 12, 2024
• Est. completion date: April 2028

Study information

• Verified date: March 2024
• Source: Frontier Medicines Corporation
• Contact: Andrew Krivoshik, MD, PhD
• Phone: +1 (650) 457-1005
• Email: andrew.krivoshik[@]frontiermeds.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 403
• Est. completion date: April 2028
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Metastatic Solid Tumor
• Neoplasms
• Non Small Cell Lung Cancer
• Pancreatic Cancer
• Solid Tumor, Adult

Intervention

Drug:
• FMC-376
Oral Capsule

Locations

Country	Name	City	State
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas
United States	START Mountain Region	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Frontier Medicines Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities	Number of participants with Dose Limiting Toxicities (DLTs)	Up to 21 Days
Primary	Adverse Events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs)	Approximately 24 Months
Secondary	Maximum Observed Plasma Concentration (Cmax) of FMC-376	Cmax	Approximately 24 Months
Secondary	Time to Reach Maximum Blood Concentration (Tmax) of FMC-376	Tmax	Approximately 24 Months
Secondary	Minimum Observed Plasma Concentration (Cmin) of FMC-376	Cmin	Approximately 24 Months
Secondary	Elimination Half-life (t1/2) of FMC-376	t1/2	Approximately 24 Months
Secondary	Area Under Blood Concentration-Time Curve (AUC) of FMC-376	AUC	Approximately 24 Months
Secondary	Volume of Distribution (Vd) of FMC-376	Vd	Approximately 24 Months
Secondary	Clearance (CL) of FMC-376 from Blood Plasma	CL	Approximately 24 Months
Secondary	Overall Response Rate (ORR)	Assess per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Approximately 24 Months
Secondary	Duration of Response (DOR)	Assess per RECIST v1.1	Approximately 24 Months
Secondary	Disease Control Rate (DCR)	Assess per RECIST v1.1	Approximately 24 Months
Secondary	Progression-Free Survival (PFS)	Assess per RECIST v1.1	Approximately 24 Months
Secondary	Overall Survival (OS)		Approximately 24 Months