drugset / Trial / NCT04942067
APG-2575 in Combination With Novel Therapeutic Regimens 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 APG-2575 in combination with Pd/DRd in patients with relapsed/refractory (RR) multiple myeloma (MM). The study consists of dose escalation and dose expansion phases. The study consists of will start with 2 arms noted below, both arms are independent
Timeline
- Start
- 2021-12-23
- Primary completion
- 2024-09-01
- Completion
- 2024-12-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | APG-2575 | Small molecule | 200 mg | — |
| Subject | APG-2575 | Small molecule | 400 mg | — |
| Subject | APG-2575 | Small molecule | 600 mg | — |
| Subject | APG-2575 | Small molecule | 800 mg | — |
| Background | Daratumumab | Monoclonal antibody | 16 mg/kg | Intravenous |
| Background | Daratumumab | Monoclonal antibody | 1800 mg | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | — |
| Background | Dexamethasone | Small molecule | 40 mg | — |
| Background | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Background | Pomalidomide | Other / unclassified | 4 mg | — |