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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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ME-344 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development and has been studied in patients with refractory solid tumors. The drug is not yet approved and remains under investigation.
ME-344 is being developed by Lite Strategy, Inc., a company traded under the ticker LITS. The company is conducting clinical research on this investigational oncology drug for solid tumors.
ME-344 is in Phase 1 clinical development. A Phase 1 dose escalation study has been completed, evaluating the safety and pharmacokinetics of ME-344 as a single agent in patients with refractory solid tumors. The drug is investigational and not yet approved.
ME-344 has one completed clinical trial, NCT01544322, titled "Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 Single Agent for Refractory Solid Tumors." This Phase 1 study enrolled 24 participants in the United States and was not randomized or blinded.
ME-344 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for solid tumors. A Phase 1 study has been completed, but the drug has not received regulatory approval.