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Also known as open label, single agent
ME-344 · 1 trial · 1 indication
Patients will be administered ME-344 IV infusions weekly for 3 weeks during the first 28 days cycle for dose limiting toxicity. Patients will be assessed by physical exam, vital signs, hematology and clinical chemistry, urinalysis, ECG, echocardiogram and pharmacokinetic sampling.
| Name | Type | Description |
|---|---|---|
| ME-344 | DRUG | experimental drug, dose escalation with 5 planned dose cohorts of 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg, 20 mg/kg; Cycle 1 is 3 weekly IV infusions on Days 1, 8, and 15. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal. Once the highest tolerated dose has been determined, patients will be enrolled to receive IV infusions 2 days each week. Cycle 1 at the highest dose level is 3 weekly IV infusions on days 1, 2, 8, 9, 15 and 16. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal. |
Inclusion Criteria: * Provision of informed consent * Male or female ≥ 18 years of age * Histologic or cytologic confirmed locally advanced or metastatic cancer that has no standard therapeutic alternatives. * ECOG Performance status 0-1 (Appendix A) * A minimum life expectancy of 12 weeks * Adequa...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ME-344 is an investigational small molecule being studied for the treatment of solid tumors. It is being developed by Lite Strategy, Inc. as a single agent for patients with refractory solid tumors, meaning tumors that have not responded to prior therapy. It has not been approved for any indication.
ME-344 targets specific subunits of mitochondrial complex I, including MT-ND6, NDUFA10, NDUFS8, MT-ND4L, NDUFA6, and MT-ND1. It acts as an inhibitor of these targets. By binding to these mitochondrial proteins, ME-344 interferes with mitochondrial electron transport, a process that tumor cells rely on for energy production and survival.
ME-344 is being developed by Lite Strategy, Inc., which trades under the ticker LITS. The company is advancing the compound as an oncology asset in its clinical pipeline.
ME-344 is in Phase 1 clinical development. It is an investigational agent and has not received FDA approval. The Phase 1 program has been completed, and no trials are currently active.
ME-344 has been evaluated in one completed Phase 1 trial, NCT01544322, titled a dose escalation study of the safety and pharmacokinetics of ME-344 single agent for refractory solid tumors. The trial enrolled 24 patients in the United States and was an uncontrolled, non-randomized study.