This is a Phase 1b open-label, multiple dose/schedule sequential study to determine the safety and efficacy of the oxidative phosphorylation (OxPhos) pathway inhibitor ME-344 in combination with bevacizumab in subjects with recurrent mCRC.
This is a Phase 1b open-label, multiple dose/schedule sequential study to determine the safety and efficacy of the oxidative phosphorylation (OxPhos) pathway inhibitor ME-344 in combination with bevacizumab in subjects with recurrent mCRC. This study will enroll subjects with metastatic CRC, including but not limited to subjects with RAS wild-type or mutant tumors, MSI-H/pMMR, and BRAF V600E, who have progressed or demonstrated intolerability to standard approved therapies which include fluoropyrimidine, oxaliplatin, irinotecan-based chemotherapies, cetuximab/panitumumab, PD-1 inhibitors, or BRAF inhibitors (if clinically indicated), and/or other checkpoint inhibitors. Approximately 40 subjects will be enrolled in the study, in 2 cohorts of 20 subjects each. Subjects will continue treatment with ME-344 and bevacizumab until radiological progressive disease, unacceptable AEs, withdrawal of consent, start of new anticancer therapy, or death.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
ME-344 will be administered intravenously (IV)
Bevacizumab will be administered intravenously (IV)
University of Southern California
Los Angeles, California, United States
Mount Sinai Miami
Miami Beach, Florida, United States
Johns Hopkins
Baltimore, Maryland, United States
Rutgers University
New Brunswick, New Jersey, United States
Progression Free Survival (PFS) Rate at 16 Weeks
Progression Free Survival is measured by using laboratory testing and scans. It is measured by the length of time from first dose of study drug until observation of disease progression.
Time frame: 16 weeks
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined/measured by the proportion of patients achieving complete response \[CR\] or partial response \[PR\] per RECIST v.1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time frame: 6 months
Treatment Emergent Adverse Events for ME-344 Administered in Combination With Bevacizumab
This will be measured by the number of participants with at least one treatment emergent Adverse Events (abnormal physical examination findings, abnormal vital signs, abnormal ECG QT interval and abnormal clinical laboratory results)
Time frame: from first dose of study drug on Cycle 1 Day 1 through 30 days after the last dose of study drug or start of new anticancer treatment, up to 11 months
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Mt Sinai New York
New York, New York, United States
Vanderbilt -Ingram Cancer Center
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States