NCT06431243 A Clinical Study of Purinostat Mesylate for Injection in Patients With Advanced Solid Tumors
| NCT ID | NCT06431243 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chengdu Zenitar Biomedical Technology Co., Ltd |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2024-05-08 |
| Primary Completion | 2026-05-01 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following inclusion criteria: 1. Age: ≥18 years and ≤75 years, regardless of gender. 2. At least one measurable lesion as defined by RECIST 1.1 during the screening period (for the breast cancer cohort in the dose-escalation phase, measurable lesions are not required if the participant has only bone metastases). 3. Phase Ib: Monotherapy Dose-Escalation Phase: 1. Monotherapy in Cohort A0 (Breast Cancer): Histologically or cytologically confirmed locally advanced or metastatic breast cancer that has failed standard treatment, for which no standard treatment is available, or for which standard treatment is not suitable at the current stage. 2. Monotherapy in Cohort B0 (Solid Tumors): Histologically or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard treatment, for which no standard treatment is available, or for which standard treatment is not suitable at the current stage. This includes but