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

Sponsor
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Study ID
NCT07154264
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 22, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination of DZD8586 and Venetoclax
    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.

Primary Outcome Measure

Part A: Incidence of Adverse Events [ Time Frame: 30 days after the last dose ]

Central Contacts

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