ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer

Stopped early · Phase 1

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT05824559

Run by

MEI Pharma, Inc.

People needed

23

Starts

2023-08-07

Expected to finish

2024-07-23

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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