ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer
Reason given: Company decision to wind down operations, close all clinical programs and evaluate strategic options
Key facts
- Where
- Baltimore, Los Angeles, Miami Beach, Nashville, New Brunswick, New York, and Salt Lake City, United StatesSee the 7 sites
- Phase
- Phase 1
Where in United States
- Johns HopkinsBaltimore, United StatesNo longer taking part
- University of Southern CaliforniaLos Angeles, United StatesNo longer taking part
- Mount Sinai MiamiMiami Beach, United StatesNo longer taking part
- Vanderbilt-Ingram Cancer CenterNashville, United StatesNo longer taking part
- Rutgers UniversityNew Brunswick, United StatesNo longer taking part
- Mt. Sinai New YorkNew York, United StatesNo longer taking part
- University of UtahSalt Lake City, United StatesNo longer taking part
Trial details
- Who runs it
- MEI Pharma, Inc.
- Trial code
- NCT05824559
- Record updated
- 21 November 2024
- Original description
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.Read full original descriptionShow less
A Phase 1b Study of the OxPhos Inhibitor ME-344 Combined With Bevacizumab in Previously Treated Metastatic Colorectal Cancer
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.
Inclusion: Age ≥18 years; Histological or cytological documentation of adenocarcinoma of the colon or rectum that is metastatic (all other histological types are excluded); Subjects who progressed or demonstrated intolerability to prior standard approved therapies which include fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapies, cetuximab/panitumumab (if clinically indicated e.g., RAS wild-type tumors) PD-1 or BRAF inhibitors (if clinically indicated), and/or other checkpoint inhibitors in the metastatic setting; Previous treatment with any investigational drug or anticancer treatment must be completed >28 days or 5 half-lives, whichever is longer, before the first dose of study treatment; Adequate bone marrow, liver, and renal function.
Exclusion: Bevacizumab or aflibercept therapy ≤ 3 weeks prior to starting study treatment; Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor; Evidence of uncontrolled or unstable cardiovascular disease, myocardial infarction (within 6 months), unstable angina pectoris, congestive heart failure, serious arrhythmias requiring drug therapy; History of CNS disease; Uncontrolled hypertension or diabetes mellitus, active peptic ulcers, unhealed wounds, clinically significant disease or systemic infections; Known seropositive for, or active infection with hepatitis B or C virus; Symptomatic or uncontrolled infection with human T-cell leukemia virus; Venous thromboembolism (unless appropriately treated and stable on anticoagulant for at least 2 weeks); Untreated brain metastases, spinal cord compression, or primary brain tumor; Peripheral neuropathy Grade ≥ 2.