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

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

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.

Study Overview

• Status: Terminated
• Conditions: Relapsed or Refractory Synovial Sarcoma
• Intervention / Treatment: Drug: OTSA101-DTPA-111In; Drug: OTSA101-DTPA-90Y

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
    • Osaka International Cancer Institute
  • Tokyo, Japan
    • National Cancer Center Hospital
  • Tokyo, Japan
    • Cancer Institute Hospital of JFCR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Study Arm, no competitor	Drug: OTSA101-DTPA-111In; single IV injection, 185MBq/body; Drug: OTSA101-DTPA-90Y; IV injection (max. 3 injections per patient), 1110MBq/body

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In	Concentration of OTSA101-DTPA in plasma and the distribution of OTSA101-DTPA in the body by imaging scan will be assessed.	up to 72 hours post dosing
Safety of OTSA101-DTPA-111In	This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.	up to 10 days post dosing
Safety of OTSA101-DTPA-90Y	This outcome will be evaluated via overall listing of Treatment-Emergent Adverse Events and the incidence of each Treatment-Emergent Adverse Event that meets DLT criteria.	up to 6 weeks post dosing

Collaborators and Investigators

• Sponsor: OncoTherapy Science, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): January 11, 2024
• Study Completion (Actual): January 11, 2024

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Sarcoma; Sarcoma, Synovial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Anticoagulants; Antidotes; Chelating Agents; Sequestering Agents; Iron Chelating Agents; Calcium Chelating Agents; Edetic Acid; Pentetic Acid
• Other Study ID Numbers: OTS3050102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No