drugset / Trial / NCT04176016

Phase I Study of Radiolabeled OTSA101-DTPA in Patients With Relapsed or Refractory Synovial Sarcoma

NCT04176016 ↗

Phase 1 Terminated 12 enrolled OncoTherapy Science, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate safety and pharmacokinetics as well as the biodistribution of OTSA101-DTPA-111In and to evaluate the safety of intravenous administration of OTSA101-DTPA-90Y.

Timeline

Start
2020-01-10
Primary completion
2024-01-11
Completion
2024-01-11

Outcome

Outcome not reported

Stopped: “Some of the raw materials for the investigational drug are difficult to obtain and expensive.”

Drugs

EvaluationDrugModalityDoseRoute
Subject OTSA101-DTPA-111In Monoclonal antibody 185 mbq Intravenous
Subject OTSA101-DTPA-90Y Monoclonal antibody 1110 mbq Intravenous

Indications