drugset / Trial / NCT02363491
A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome
Phase 1/2
Completed
96 enrolled
Opsona Therapeutics Ltd.
H. Lee Moffitt Cancer Center and Research Institute · collabM.D. Anderson Cancer Center · collabMontefiore Medical Center · collabNew York Presbyterian Hospital · collab
NaSingle-groupOpen-labelTreatment
Summary
The dose-confirming part of this study, comprising at least 10 patients is designed as a single center, prospective, single arm, open label in patients who have failed or are unresponsive to Azacitidine (AZA) or Decitabine (they may also have additionally failed an Erythropoiesis Stimulating Agent (ESA) followed by a dose expansion part with at least 44 patients; the objective of the whole study being to assess the safety, efficacy, pharmacokinetics and pharmacodynamics of intravenously infused multiple doses of OPN-305 in low and intermediate-1 risk myelodysplastic syndrome (second and third line Lower risk MDS).
Timeline
- Start
- 2015-01
- Primary completion
- 2018-12
- Completion
- 2018-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TOMARALIMAB | Monoclonal antibody | 5 mg/kg | Intravenous |