NCT06431243

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

An Open, Multicenter Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the Purinostat Mesylate for Injection in Combination Therapy for Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Chengdu Zenitar Biomedical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	A0/B0 group Purinostat Mesylate 11.2mg/m2	Purinostat Mesylate 11.2mg/m2
DRUG	A0/B0 group Purinostat Mesylate 15mg/m2	Purinostat Mesylate 15mg/m2
DRUG	A group Purinostat Mesylate 6mg/m2	Purinostat Mesylate 6mg/m2 + FS 500mg
DRUG	A group Purinostat Mesylate 8.4mg/m2	Purinostat Mesylate 8.4mg/m2 + FS 500mg
DRUG	A group Purinostat Mesylate 11.2mg/m2	Purinostat Mesylate 11.2mg/m2 + FS 500mg
DRUG	A group Purinostat Mesylate 15 mg/m2	Purinostat Mesylate 15 mg/m2 + FS 500mg
DRUG	B group Purinostat Mesylate 6 mg/m2	Purinostat Mesylate 6mg/m2 + Tislelizumab 200mg
DRUG	B group Purinostat Mesylate 8.4 mg/m2	Purinostat Mesylate 8.4mg/m2 + Tislelizumab 200mg
DRUG	B group Purinostat Mesylate 11.2mg/m2	Purinostat Mesylate 11.2mg/m2 + Tislelizumab 200mg
DRUG	B group Purinostat Mesylate 15mg/m2	Purinostat Mesylate 15mg/m2 + Tislelizumab 200mg

Timeline

• Start date: 2024-05-08
• Primary completion: 2026-05-01
• Completion: 2026-11-01
• First posted: 2024-05-28
• Last updated: 2025-04-10

Locations

2 sites across 1 country: China