ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer

NCT05824559 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: ME-344-003
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 7

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (2)

• Overall Response Rate (ORR)

  6 months

• Treatment Emergent Adverse Events for ME-344 Administered in Combination With Bevacizumab

  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

Study Arms (1)

ME-344 and Bevacizumab

EXPERIMENTAL

ME-344 (IV) Cohort 1: Days 1, 8, and 15 of each 28-day cycle. Cohort 2: Days 1 and 15 of each 28-day cycle. Bevacizumab (IV) Cohorts 1 and 2: Days 1 and 15 of each 28-day cycle.

Drug: ME-344; Drug: Bevacizumab

Interventions

ME-344 DRUG

ME-344 will be administered intravenously (IV)

ME-344 and Bevacizumab

Bevacizumab DRUG

Bevacizumab will be administered intravenously (IV)

ME-344 and Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• MEI Pharma, Inc.: lead

Study Sites (7)

University of Southern California

Los Angeles, California, 90033, United States

Location

Mount Sinai Miami

Miami Beach, Florida, 33140, United States

Location

Johns Hopkins

Baltimore, Maryland, 21218, United States

Location

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Mt Sinai New York

New York, New York, 10029, United States

Location

Vanderbilt -Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (1)

• Boland PM, Lenz HJ, Ciombor KK, Florou V, Pishvaian MJ, Cusnir M, Cohen D, Guo JY, Tang M, Rajagopalan P, Wiley SE, Ghalie RG, Hochster HS. A Phase 1b study of the OxPhos inhibitor ME-344 with bevacizumab in refractory metastatic colorectal cancer. Invest New Drugs. 2025 Feb;43(1):60-68. doi: 10.1007/s10637-024-01489-1. Epub 2024 Dec 27.

  PMID: 39725778 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

ME-344; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Richard Ghalie, MD CMO
• Organization: MEI Pharma

rghalie@meipharma.com

619 990-1153

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. Subjects in Cohort 1 will receive ME-344 (IV) on Days 1, 8 and 15 combined with bevacizumab (IV) on Days 1 and 15 of each 28-day cycle. Subjects in Cohort 2 will receive ME 344 (IV) on Days 1 and 15 combined with bevacizumab (IV) on Days 1 and 15 of each 28-day cycle.

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 21, 2023
• Study Start: August 7, 2023
• Primary Completion: July 9, 2024
• Study Completion: July 23, 2024
• Last Updated: November 21, 2024
• Results First Posted: November 21, 2024

Record last verified: 2024-06

Locations

US (7)