A Phase I/II Study of OPN-305 in Second-line Lower Risk Myelodysplastic Syndrome
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Opsona Therapeutics Ltd.
Collaborators:
H. Lee Moffitt Cancer Center and Research Institute M.D. Anderson Cancer Center Montefiore Medical Center New York Presbyterian Hospital