Clinical trial · Interventional
ME-344 and Bevacizumab in Previously Treated Metastatic Colorectal Cancer
A Phase 1b Study of the OxPhos Inhibitor ME-344 Combined With Bevacizumab in Previously Treated Metastatic Colorectal Cancer
NCT05824559CI-TRIAL-00082876terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company decision to wind down operations, close all clinical programs and evaluate strategic options
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| ME-344 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ME-344 and Bevacizumab
- description
- 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.
- interventionNames
- Drug: ME-344
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) Rate at 16 Weeks
- timeFrame
- 16 weeks
- description
- 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.
Secondary outcomes (2)
- measure
- Overall Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (1)
- DERIVEDBoland 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