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

NCT04176016 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-02-02

No results posted yet for this study

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.

Conditions

  • Relapsed or Refractory Synovial Sarcoma

Interventions

DRUG

OTSA101-DTPA-111In

single IV injection, 185MBq/body

DRUG

OTSA101-DTPA-90Y

IV injection (max. 3 injections per patient), 1110MBq/body

Sponsors & Collaborators

  • OncoTherapy Science, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04176016 on ClinicalTrials.gov