DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)

A Phase 2, Open-label, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Drug: DZD8586; Drug: DZD8586; Drug: DZD8586

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230031
      • Research Site
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100083
      • Research Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Research Site
  • Guangxi
    • Nanning, Guangxi, China, 530016
      • Research Site
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Research Site
  • Hubei
    • Wuhan, Hubei, China, 430023
      • Research Site
  • Hunan
    • Changsha, Hunan, China, 410031
      • Research Site
  • Shandong
    • Jinan, Shandong, China, 250117
      • Research Site
    • Linyi, Shandong, China, 276002
      • Research Site
  • Shanxi
    • Xi’an, Shanxi, China, 710061
      • Research Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Research Site
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
    • Tianjin, Tianjin Municipality, China, 300181
      • Research Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants who meet all the following criteria:

1. Male and female ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Histologically confirmed recurrent or refractory DLBCL.
4. Adequate bone marrow reserve and organ system functions.
5. Willing to comply with contraceptive restrictions

Exclusion Criteria:

Participants who meet any of the following criteria:

1. CNS involvement
2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives. Monoclonal antibodies and antibody-drug conjugates within 28 days.
3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
5. Active infection.
6. Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
8. Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
9. Women who are breast feeding.
10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Daily dose of DZD8586 at 25 mg	Drug: DZD8586; Daily dose of DZD8586 at 25 mg; Drug: DZD8586; Daily dose of DZD8586 at 50 mg; Drug: DZD8586; Daily dose of DZD8586 at 75 mg
Experimental: Daily dose of DZD8586 at 50 mg	Drug: DZD8586; Daily dose of DZD8586 at 25 mg; Drug: DZD8586; Daily dose of DZD8586 at 50 mg; Drug: DZD8586; Daily dose of DZD8586 at 75 mg
Experimental: Daily dose of DZD8586 at 75 mg	Drug: DZD8586; Daily dose of DZD8586 at 25 mg; Drug: DZD8586; Daily dose of DZD8586 at 50 mg; Drug: DZD8586; Daily dose of DZD8586 at 75 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate assessed by investigators	Assessed up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events	30 days after the last dose, assessed up to 2 years

Collaborators and Investigators

• Sponsor: Dizal Pharmaceuticals
• Investigators: Principal Investigator: Lugui Qiu, National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: DZ2023B0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No