drugset / Trial / NCT06351644
ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
NaSingle-groupOpen-labelTreatment
Summary
Multiple myeloma (MM) is a malignancy characterized by uncontrolled proliferation of plasma cells for which there is an urgent and unmet need to develop new, effective therapeutics. Onconova Therapeutics has developed a first-in-class oral inhibitor of CDK4 and ARK5 ON 123300 (NARAZACICLIB) which shows potent anti-myeloma activity in vitro and in vivo in preclinical models, and is undergoing evaluation in Phase 1-2 trials worldwide. In this study, the researchers will test the safety and preliminary efficacy of inhibition of CDK4 and ARK5 by ON 123300 (NARAZACICLIB) in combination with dexamethasone in myeloma patients in a Phase I/II clinical trial.
Timeline
- Start
- 2024-10-02
- Primary completion
- 2025-04-28
- Completion
- 2025-04-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Narazaciclib | Small molecule | 160 mg | Oral |
| Subject | Narazaciclib | Small molecule | 200 mg | Oral |
| Subject | Narazaciclib | Small molecule | 240 mg | Oral |
| Subject | Narazaciclib | Small molecule | 280 mg | Oral |
| Subject | Narazaciclib | Small molecule | 320 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |