A Study of DZD8586 Combination in CLL/SLL (TAI-SHAN10)

Dizal Pharma

Status and phase: Enrolling; Phase 2

Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Treatments: Drug: Venetoclax; Drug: DZD8586

Study type: Interventional

Funder types: Industry

Identifiers

NCT07154264

DZ2025B0001

Details and patient eligibility

About

This is a phase 2 study to investigate the efficacy and safety of DZD8586 in combination in participants with CLL/SLL.

This study consists of two parts: Part A is the safety lead-in phase, and Part B is the dose expansion phase.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male and female ≥ 18 years of age.
2. ECOG performance status 0-2, and life expectancy ≥ 6 months.
3. Confirmed newly diagnosis or treatment naïve CLL/SLL with indication for treatment.
4. Patients with SLL must have at least one measurable lesion.
5. Adequate bone marrow reserve and organ functions.
6. Willing to comply with contraceptive restrictions.

Exclusion criteria

1. Any of previous or current treatment prohibited by protocol.
2. Any unresolved > grade 1 drug-related adverse events.
3. Known or suspected Richter's transformation, or prolymphocytic leukemia.
4. CNS involvement.
5. Active infection.
6. Any of severe cardiac or pulmonary abnormalities.
7. Poorly controlled autoimmune anemia or autoimmune thrombocytopenia.
8. Poorly controlled gastrointestinal disorder, inadequate absorption of medication or other systemic diseases.
9. Prior malignancy within the past 3 years.
10. Known allergy to study drugs, any of the ingredients of the study drugs, or xanthine oxidase inhibitors or rasburicase.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

66 participants in 1 patient group

Combination of DZD8586 and Venetoclax

Experimental group

Description:

DZD8586 will be taken orally once daily on days 1-28 of each cycle. Venetoclax will be taken orally once daily on days 1-28 starting from cycle 4 day 1.

Treatment:

Drug: DZD8586

Drug: Venetoclax