UPCC 09924 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 (PROSPER)

Investigational Study on Advanced Solid Tumors with KRAS G12C Mutation

Enrolling By Invitation
18 years or above
All
Phase 1/2
403 participants needed
1 Location

Brief description of study

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 of study

You may be eligible for this study if you meet the following criteria:

  • 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
  • Age: 18 years or above
  • Gender: All

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

This study investigates the safety and clinical activity of an investigational medication in participants with advanced solid tumors that have a specific genetic mutation known as KRAS G12C. The purpose of this study is to evaluate how the investigational medication works in different phases, including dose escalation and expansion, to determine appropriate dosing levels.

Participants in this study will undergo various procedures, including regular monitoring of their health status and assessments of how the investigational medication affects their tumor. The study will be conducted in multiple parts to explore different dose levels and their effects on the participants' conditions.

  • Who can participate: Adults with locally advanced unresectable or metastatic solid tumors with a KRAS G12C mutation may be eligible. Participants should have progressed on or been intolerant to prior treatment, or where standard therapy is inappropriate. They must have an ECOG performance status of 0 or 1 and adequate organ function.
  • Study details: Participants will receive the investigational medication and be monitored for safety and efficacy. They must agree not to join other interventional studies during this trial.
Updated on 18 Mar 2026. Study ID: 24-0797
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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