Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL

Sponsor
Ascentage Pharma Group Inc.
Study ID
NCT04494503
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • APG-2575 — DRUG
    APG-2575 orally once daily, every 28 days as a cycle.
  • Rituximab — DRUG
    Rituximab 375mg/m2 ivgtt on C1D8 and 500mg/m2 ivgtt on C2-6D1.
  • Ibrutinib — DRUG
    Ibrutinib 420mg orally once daily during C1D8-28 and following cycles.

Study Details

The purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-2575 single agent and in combination with other therapeutic agents in patients with relapsed/refractory CLL/SLL.

Key Dates

First listed
Jul 31, 2020
Start date
Aug 31, 2020
Status verified
Apr 2025
Primary completion
Oct 20, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
123 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: APG-2575 single agent in Relapse/Refractory CLL/SLL
    APG-2575 orally once daily at 400mg, 600mg, 800mg dose levels respectively, every 28 days as a cycle.
  • Experimental: APG-2575+Rituximab in Relapse/Refractory CLL/SLL
    Stage 1:APG-2575 orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg. Rituximab 375mg/m2 ivgtt on C1D8 and 500mg/m2 ivgtt on C2-6D1. Every 28 days as a cycle. Stage 2: APG-2575 MTD/RP2D combined with rituximab. Every 28 days as a cycle.
  • Experimental: APG-2575+ibrutinib in Relapse/Refractory CLL/SLL
    Stage 1: APG-2575 orally once daily starting from 200mg and will be increased in subsequent cohorts to 400mg, 600mg, 800mg.Ibrutinib 420mg orally once daily during C1D8-28 and following cycles. Every 28 days as a cycle. Stage 2: APG-2575 MTD/RP2D combined with ibrutinib. Every 28 days as a cycle.

Primary Outcome Measure

Adverse events of APG-2575 single agent [ Time Frame: Up to 6 cycles (each cycle is 28 days). ]

Central Contacts

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