drugset / Trial / NCT04245397
Study of SX-682 Alone and in Combination With Oral or Intravenous Decitabine in Subjects With Myelodysplastic Syndrome
Phase 1
Recruiting
151 enrolled
Syntrix Biosystems, Inc.
AdventHealth · collabEmory University · collabH. Lee Moffitt Cancer Center and Research Institute · collabMayo Clinic · collabMontefiore Medical Center · collabNational Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabSidney Kimmel Comprehensive Cancer Center at Johns Hopkins · collabUniversity of Miami · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This study will determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT), and recommended Phase 2 dose (RP2D) of SX-682 in the treatment of patients with Myelodysplastic Syndromes (MDS).
Timeline
- Start
- 2020-06-30
- Primary completion
- 2028-03
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | — | Oral |
| Subject | SX-682 | Small molecule | 25 mg | Oral |
| Subject | SX-682 | Small molecule | 50 mg | Oral |
| Subject | SX-682 | Small molecule | 100 mg | Oral |
| Subject | SX-682 | Small molecule | 200 mg | Oral |
| Subject | SX-682 | Small molecule | 400 mg | Oral |