Recruiting PHASE1, PHASE2 Advanced Solid Tumors With KRAS G12C Mutations

New treatment option for Advanced Solid Tumors With KRAS G12C Mutations

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

ClinicalTrials.gov ID: NCT06244771

What this study is testing

What is FMC-376?

FMC-376 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced solid tumors with kras g12c mutations.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematological, renal, and hepatic function
  • Agrees not to participate in another treatment study while receiving study drug

You likely can't join if

  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • La Jolla, California, United States
  • Orange, California, United States
  • San Francisco, California, United States
  • Lake Mary, Florida, United States
  • Dyer, Indiana, United States
  • Fairway, Kansas, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • Philadelphia, Pennsylvania, United States
  • Houston, Texas, United States
  • Kingwood, Texas, United States
  • San Antonio, Texas, United States
  • West Valley City, Utah, United States
  • Fairfax, Virginia, United States
  • Macquarie Park, New South Wales, Australia
  • Southport, Queensland, Australia
  • Kurralta Park, South Australia, Australia
  • North Adelaide, South Australia, Australia
  • Box Hill, Victoria, Australia
  • Nedlands, Western Australia, Australia

+ 5 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include La Jolla, California, United States; Orange, California, United States; San Francisco, California, United States; Lake Mary, Florida, United States; Dyer, Indiana, United States; Fairway, Kansas, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.