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

Launched by FRONTIER MEDICINES CORPORATION · Jan 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called FMC-376 for patients with advanced solid tumors that have a specific genetic change known as the KRAS G12C mutation. These tumors can include types like lung cancer, colorectal cancer, and pancreatic cancer. The trial is divided into three parts, where researchers will gradually increase the dose of the treatment to find the most effective amount and then expand to include more participants to see how well it works in different settings.

To be eligible for this trial, participants need to have a confirmed diagnosis of an advanced solid tumor with the KRAS G12C mutation, must have tried other treatments without success, and should be in relatively good health (with a performance status of 0 or 1, which means they are fully active or have mild symptoms). Participants will receive the study drug and will be monitored closely for any side effects and how their tumors respond. It's important to note that individuals with certain conditions, such as severe reactions to past treatments or specific types of disease, may not be able to join the study. This trial is currently recruiting participants, and everyone involved will play a vital role in understanding how FMC-376 can help those with these challenging cancers.

Gender

ALL

Eligibility criteria

• 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