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A Phase Ib/II Open-Label Study of APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple Myeloma and Immunoglobin Light Chain Amyloidosis
Ascentage Pharma Group Inc.
This study has two arms, which are independent of each other, and each arm consists of dose escalation and dose expansion phases. In the dose escalation phase, APG-2575 will be administered at increasing doses until the recommended phase 2 dose (RP2D) is determined.
In Arm 1, participants will receive APG-2575 in combination with Pomalidomide (4mg daily x 21 days) and dexamethasone (40mg for patients ≤ 75 years old or 20 mg for patients > 75 years old; on Days 1, 8, 15, and 22 of a repeated 28-day cycle).
In Arm 2, participants will receive APG2575 in combination with Lenalidomide (25mg orally on Days 1-21 of each 28-day cycle), dexamethasone (40 mg [or 20 mg for patients > 75 years old] once weekly), and daratumumab (administered intravenously, 16mg/kg weekly in cycles 1 and 2 and then every 2 weeks in cycles 3-6 and every 4 weeks thereafter).