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

NCT04176016 | Terminated Phase 1 DMC

• 1 other identifier: OTS3050102
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Single Study Arm, no competitor

EXPERIMENTAL

Drug: OTSA101-DTPA-111In; Drug: OTSA101-DTPA-90Y

Interventions

OTSA101-DTPA-111In DRUG

single IV injection, 185MBq/body

Single Study Arm, no competitor

OTSA101-DTPA-90Y DRUG

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

Single Study Arm, no competitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a documented relapsed or refractory synovial sarcoma after standard chemotherapy
• Patients ≥18 years of age at the time of obtaining informed consent
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Patients with measurable lesion
• Patients not received any anti-malignancy agent or specified surgical intervention within 28 days or specified radiotherapy within 14 days prior to study registration.
• Patients without any clinically significant laboratory abnormality.
• Patients with adequate heart function as measured by echocardiography or multiple gated acquisition scan (MUGA).
• Patients with adequate pulmonary function as measured by pulmonary function tests.
• 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
• Patients must be able to understand and be willing to sign a written informed consent

You may not qualify if:

• Patients with documented concurrent malignancy.
• Patients with brain metastasis with clinical symptoms.
• Patients with any infection requiring systemic treatment.
• Patients with lung inflammation or pulmonary fibrosis.
• Patients with a known history of hypersensitivities to antibody agents or serum albumin agents.
• Patients with a known history of autoimmune diseases.
• Patients with myocardial infarction (MI) within 6 months prior to study registration.
• Patients with uncontrolled diseases.
• Patients with any disease requiring continuous systemic administration of steroids or immunosuppressants.
• Patients with evidence of active HBV, HCV or HIV infection.
• Pregnant or breastfeeding female patients, or female patients with suspected pregnancy.
• Patients who are participating any other investigational treatments during the study.
• Patients with psychiatric disorders and is considered to have difficulty to study participation.

Sponsors & Collaborators

• OncoTherapy Science, Inc.: lead

Study Sites (3)

Osaka International Cancer Institute

Osaka, Japan

Location

Cancer Institute Hospital of JFCR

Tokyo, Japan

Location

National Cancer Center Hospital

Tokyo, Japan

Location

MeSH Terms

Conditions

Recurrence; Sarcoma, Synovial

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 25, 2019
• Study Start: January 10, 2020
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)