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

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

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

Sponsors & Collaborators

• Chengdu Zenitar Biomedical Technology Co., Ltd

  lead INDUSTRY

Principal Investigators

• Herui Yao, Doctor · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

• Yongsheng Wang, Doctor · West China Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-08

Primary Completion

2026-05-01

Completion

2026-11-01

Countries

• China

Study Locations