Clinical Trial

A Clinical Study of Purinostat Mesylate for Injection in Patients With Advanced Solid Tumors

Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated April 10, 2025 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Primary Objectives Phase Ib To evaluate the safety and tolerability of Purinostat Mesylate in combination therapy for advanced solid tumors; and to explore the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of Purinostat Mesylate in combination therapy in patients with advanced solid tumors. To determine the recommended Phase II dose (RP2D) of Purinostat Mesylate in combination therapy for advanced solid tumors. Phase IIa To further evaluate the preliminary efficacy of Purinostat Mesylate in combination therapy in patients with advanced solid tumors. Secondary Objectives Phase Ib To evaluate the safety and tolerability of Purinostat Mesylate Monotherapy for the treatment of advanced solid tumors; To evaluate the preliminary efficacy of Purinostat Mesylate in combination therapy in patients with advanced solid tumors; To evaluate the pharmacokinetic characteristics of Purinostat Mesylate in combination therapy for the treatment of advanced solid tumors. Phase IIa To further evaluate the safety and tolerability of Purinostat Mesylate in combination therapy for advanced solid tumors. To evaluate the pharmacokinetic characteristics of Purinostat Mesylate in combination therapy for advanced solid tumors. Exploratory Objectives To assess the pharmacodynamic characteristics in Purinostat Mesylate combination therapy for advanced solid tumors.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-24; most recent amendment 2025-04-07.
Status change: Not Yet Recruiting → Recruiting 2025-03-13
Trial Details
NCT Number NCT06431243
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions Advanced Solid Tumor
Enrollment 132 participants
Start Date 2024-05-08
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-10