ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEI Pharma, Inc.
• Treatments: Bevacizumab

Criteria

Inclusion 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

Exclusion Criteria:

• 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).