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

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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