drugset / Trial / NCT04674514
APG-2575 Monotherapy or in Combination With Lenalidomide/DXMS in Subjects With Relapsed or Refractory Multiple Myeloma
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase Ib/II, open-label, multi-center study evaluating the safety, tolerability, efficacy, and PK/ Pharmacodynamics of APG2575 monotherapy or in combination with lenalidomide (R) and dexamethasone (d) in patients with relapsed/refractory (R/R) multiple myeloma (MM). The primary objective is to evaluate the safety and tolerability, identify dose-limiting toxicities (DLT), the maximum tolerated dose (MTD) and the recommended dose (RP2D) of APG-2575 monotherapy or in combination with Rd in Chinese R/R MM patients.
Timeline
- Start
- 2021-04-13
- Primary completion
- 2024-01
- Completion
- 2024-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APG-2575 | Small molecule | — | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | — |
| Background | Dexamethasone | Small molecule | 40 mg | — |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |