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

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

All Phases

To characterize the safety and tolerability of FMC-376 in participants with locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
To characterize the PKs profile of FMC-376
To evaluate the anti-tumor activity of FMC-376 using RECIST v1.1

Phase 1 (A & B) Only

Eligibility

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices