Clinical Trials /

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

NCT04176016

Description:

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.

Related Conditions:
  • Synovial Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase I Study of Radiolabeled OTSA101-DTPA in Patients With Relapsed or Refractory Synovial Sarcoma
  • Official Title: Safety Study of Radiolabeled (111In or 90Y) OTSA101-DTPA, an Anti-Frizzled Homolog 10 (FZD10) Monoclonal Antibody, to Evaluate Safety and Pharmacokinetics in Patients With Relapsed or Refractory Synovial Sarcoma

Clinical Trial IDs

  • ORG STUDY ID: OTS3050102
  • NCT ID: NCT04176016

Conditions

  • Relapsed or Refractory Synovial Sarcoma

Interventions

DrugSynonymsArms
OTSA101-DTPA-111InSingle Study Arm, no competitor
OTSA101-DTPA-90YSingle Study Arm, no competitor

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Single Study Arm, no competitorExperimental
  • OTSA101-DTPA-111In
  • OTSA101-DTPA-90Y

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with a documented relapsed or refractory synovial sarcoma after standard
             chemotherapy

          2. Patients ≥18 years of age at the time of obtaining informed consent

          3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
             0 or 1

          4. Patients with measurable lesion

          5. Patients not received any anti-malignancy agent or specified surgical intervention
             within 28 days or specified radiotherapy within 14 days prior to study registration.

          6. Patients without any clinically significant laboratory abnormality.

          7. Patients with adequate heart function as measured by echocardiography or multiple
             gated acquisition scan (MUGA).

          8. Patients with adequate pulmonary function as measured by pulmonary function tests.

          9. Patients who are either not of childbearing potential or who agree to use a
             contraception method during the study and for 12 months after the last dose of study
             drug

         10. Patients must be able to understand and be willing to sign a written informed consent

        Exclusion Criteria:

          1. Patients with documented concurrent malignancy.

          2. Patients with brain metastasis with clinical symptoms.

          3. Patients with any infection requiring systemic treatment.

          4. Patients with lung inflammation or pulmonary fibrosis.

          5. Patients with a known history of hypersensitivities to antibody agents or serum
             albumin agents.

          6. Patients with a known history of autoimmune diseases.

          7. Patients with myocardial infarction (MI) within 6 months prior to study registration.

          8. Patients with uncontrolled diseases.

          9. Patients with any disease requiring continuous systemic administration of steroids or
             immunosuppressants.

         10. Patients with evidence of active HBV, HCV or HIV infection.

         11. Pregnant or breastfeeding female patients, or female patients with suspected
             pregnancy.

         12. Patients who are participating any other investigational treatments during the study.

         13. Patients with psychiatric disorders and is considered to have difficulty to study
             participation.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In
Time Frame:up to 72 hours post dosing
Safety Issue:
Description:Concentration of OTSA101-DTPA in plasma and the distribution of OTSA101-DTPA in the body by imaging scan will be assessed.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:OncoTherapy Science, Inc.

Last Updated

November 21, 2019