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RECRUITING
NCT06539182
PHASE2

DZD8586 in Patients With Relapsed or Refractory CLL/SLL (TAI-SHAN8)

Sponsor: Dizal Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will treat patients with CLL/SLL whose disease comes back or is not responding to prior therapy, or if they can not bear side effects of the prior treatment. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.

Official title: A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

155

Start Date

2024-04-29

Completion Date

2028-03

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

DRUG

DZD8586

Daily oral dose of DZD8586 at 25 mg.

DRUG

DZD8586

Daily oral dose of DZD8586 at 50 mg.

DRUG

DZD8586

Daily oral dose of DZD8586 at 75 mg.

Locations (17)

Research Site

Hefei, Anhui, China

Research Site

Beijing, Beijing Municipality, China

Research Site

Beijing, Beijing Municipality, China

Research Site

Guangzhou, Guandong, China

Research Site

Guangzhou, Guandong, China

Research Site

Zhengzhou, Henan, China

Research Site

Wuhan, Hubei, China

First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Nanjing, Jiangsu, China

Research Site

Changchun, Jilin, China

Research Site

Dalian, Liaoning, China

Research Site

Shenyang, Liaoning, China

Research Site

Jinan, Shandong, China

Research Site

Linyi, Shandong, China

Research Site

Shanghai, Shanghai Municipality, China

Research Site

Taiyuan, Shangxi, China

Research Site

Tianjin, Tianjin Municipality, China

Research Site

Tianjin, Tianjin Municipality, China