Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01544322 | Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 Single Agent for Refractory Solid Tumors | PHASE1 | COMPLETED | 24 | — | — | May 1, 2012 | Aug 1, 2014 | Jun 18, 2015 | 3 | United States |
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...
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|---|---|---|---|---|
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