A Phase 1b Study of the OxPhos Inhibitor ME-344 Combined With Bevacizumab in Previously Treated Metastatic Colorectal Cancer
Description
Brief Summary
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.
Detailed 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.
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.
Phase
N/AInclusion and Exclusion Criteria
- 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
- Untreated brain metastases, spinal cord compression, or primary brain tumor
- 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
- Bevacizumab or aflibercept therapy ≤ 3 weeks prior to starting study treatment
- Peripheral neuropathy Grade ≥ 2
- 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).
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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