Clinical trial NCT06539195: DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)
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 Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Dizal Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-08-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate assessed by investigators
timeFrame: Assessed up to 2 years
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 30 days after the last dose, assessed up to 2 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Nanning
country: China
facility: Research Site
state: Guangxi
city: Zhengzhou
country: China
facility: Research Site
state: Henan
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Dalian
country: China
facility: Research Site
state: Liaoning
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Linyi
country: China
facility: Research Site
state: Shandong
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Tianjin
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
name: Lugui Qiu
role: PRINCIPAL_INVESTIGATOR
References: