drugset / Trial / NCT05986240
Danvatirsen Monotherapy Followed by Combination With Venetoclax in Relapsed/Refractory MDS & AML
Phase 1
Recruiting
38 enrolled
Montefiore Medical Center
Flamingo Therapeutics NV · collabM.D. Anderson Cancer Center · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1 study investigating the safety and efficacy of Danvatirsen as a monotherapy followed by combination with Venetoclax in patients with relapsed/refractory myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML). Funding Source: FDA OOPD
Timeline
- Start
- 2024-05-08
- Primary completion
- 2027-06
- Completion
- 2030-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Danvatirsen | Antisense oligonucleotide | 1 mg/kg | Other |
| Subject | Danvatirsen | Antisense oligonucleotide | 2 mg/kg | Other |
| Subject | Danvatirsen | Antisense oligonucleotide | 3 mg/kg | Other |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |