← Landscape

Trial NCT06244771

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

Phase
Phase 1/2
Sponsor
Frontier Medicines Corporation
Conditions
Advanced Solid Tumors With KRAS G12C Mutations; Solid Tumor, Adult; Unresectable Solid Tumor; Metastatic Solid Tumor; Non Small Cell Lung Cancer; KRAS G12C
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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 * NSCLC Participants (in the first-line advanced or metastatic setting who refused standard therapy or standard therapy was considered inappropriate) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1Performance status * Adequate hematological, renal, and hepatic function * Agrees not to participate in another interventional study while receiving study drug * For patients receiving FMC-376 in combination with pembrolizumab: No history of autoimmune disease, and no history of immune-related adverse events or hepatitis Exclusion Criteria: * Leptomeningeal disease or carcinomatous meningitisBrain metastases * 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 * For patients receiving FMC-376 in combination with pembrolizumab: Has severe hypersensitivity (≥ Grade 3) to pembrolizumab, history of radiation-related toxicities, or history of non-infectious pneumonitis.

Restrictions found (2)

Recruiting in Massachusetts

  • Dana-Farber Cancer Institute · Boston, Suffolk County