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
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)
- Brain metastasesOutrightexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text
Recruiting in Massachusetts
- Dana-Farber Cancer Institute · Boston, Suffolk County