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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
Breast,Gastrointestinal (GI),Gynecologic,Lung
Karmanos Trial ID
2024-012
NCT ID
NCT06244771
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I/II
Principal Investigator
Hirva
Mamdani, M.D.
Lung Cancer Screening, Oncology - Medical
View Profile
Objective:
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
To establish the MTD and/or the RP2D and regimen of FMC-376
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NCI Dictionary of Cancer Terms
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
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
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Breast; Cervix; Colon; Lung; Ovary; Rectum
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy
Drugs
FMC-376
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