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

StatusRecruiting
PhasePhase 1/2
Started
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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.

Record History

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  1. Enrollment target: 120 to 132v3 Show 7 more changesShow less
    • Start date: May 31, 2024 to May 8, 2024
    • Interventions: A group Purinostat Mesylate 11.2mg/m2 (Drug), A group Purinostat Mesylate 15.0mg/m2 (Drug), A group Purinostat Mesylate 6mg/m2 (Drug), A… to A group Purinostat Mesylate 11.2mg/m2 (Drug), A group Purinostat Mesylate 15 mg/m2 (Drug), A group Purinostat Mesylate 6mg/m2 (Drug), A…
    • Eligibility criteria shortened, about 235 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Study sites revised (2)
    • Study arms: 2 to 4
    • Study title expanded, about 1 word
  2. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    • Study title revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06431243
Lead Sponsor Chengdu Zenitar Biomedical Technology Co., Ltd
Conditions
(from sponsor)		 Advanced Solid Tumor
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov