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

NCT06244771 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2026-03-18

No results posted yet for this study

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

DRUG

FMC-376

Oral Capsule Daily

Sponsors & Collaborators

  • Frontier Medicines Corporation

    lead INDUSTRY

Principal Investigators

  • Medical Lead · Frontier Medicines Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-12
Primary Completion
2027-10-31
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06244771 on ClinicalTrials.gov