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

Dizal Pharma

Status and phase: Enrolling; Phase 2

Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Treatments: Drug: DZD8586

Study type: Interventional

Funder types: Industry

Identifiers

NCT06539182

DZ2023B0002

Details and patient eligibility

About

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.

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants who meet all the following criteria:

1. Male and female ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Confirmed diagnosis of relapsed or refractory CLL/SLL with indication for treatment.
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 or Richter transformation.
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 or abnormalities. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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155 participants in 3 patient groups

Daily dose of DZD8586 at 25 mg

Experimental group

Treatment:

Drug: DZD8586

Drug: DZD8586

Drug: DZD8586

Daily dose of DZD8586 at 50 mg

Experimental group

Treatment:

Drug: DZD8586

Drug: DZD8586

Drug: DZD8586

Daily dose of DZD8586 at 75 mg

Experimental group

Treatment:

Drug: DZD8586

Drug: DZD8586

Drug: DZD8586