Official Title: An Open-Label, Phase I/II Dose-Escalation, Dose Expansion and Cohort Expansion Study Evaluating the Safety, PK and Clinical Activity of FMC-376 in Participants with KRASG12C Mutated Locally Advanced Unresectable or Metastatic Solid Tumors
A Study On:
Anus
Bones and Joints
Brain and Nervous System
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Eye and Orbit
Ill-Defined Sites
Kaposis sarcoma
Kidney
Larynx
Lip Oral Cavity and Pharynx
Liver
Lung
Melanoma skin
Mycosis Fungoides
Other Digestive Organ
Other Endocrine System
Other Female Genital
Other Male Genital
Other Respiratory and Intrathoracic Organs
Other Skin
Other Urinary
Ovary
Pancreas
Prostate
Rectum
Small Intestine
Soft Tissue
Stomach
Thyroid
Unknown Sites
Urinary Bladder
Study Description
The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.
Eligibility
-Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation
-You 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
-You agree not to participate in another interventional study while receiving study drug
-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
Interested in Participating in this Trial?
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.
Privacy Policy
University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research
In the instance of parental permission, “You” refers to “Your child.”
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Researchers will use your information to conduct this study. Once the study is done using your
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Data Retention - In accordance with UC Office of the President policy, information will be retained for
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