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A Phase I, Open-Label, Multicenter, Dose Escalation, Dose Expansion Study of PRT543 in Patients with Advanced Solid Tumors and Hematologic Malignancies
This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with advanced cancers who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT543.
Primary: To describe any dose limiting toxicities (DLT) of PRT543, and to determine the maximally tolerated dose (MTD) and recommended phase II dose (RP2D) and schedule of PRT543, in patients with advanced solid tumors and certain hematologic malignancies Secondary: 1.To describe the adverse event profile and tolerability of PRT543 2.To describe the pharmacokinetic profile of PRT543 3.To describe any anti-tumor activity of PRT543 based on the measurement of objectiveresponses to PRT543 according to the RECIST 1.1 criteria for patients with solid tumorsand the disease-specific response criteria for patients with hematologic malignancies
Jakafi (Ruxolitinib); PRT543 (); Ruxolitinib ()