NCT06244771

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 403 (estimated)
• Sponsor: Frontier Medicines Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	FMC-376	Oral Capsule Daily

Timeline

• Start date: 2024-02-12
• Primary completion: 2027-10-01
• Completion: 2028-04-01
• First posted: 2024-02-06
• Last updated: 2026-03-18

Locations

26 sites across 3 countries: United States, Australia, South Korea

Regulatory

• FDA-regulated drug study