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

NCT ID: NCT04176016

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2024-01-11

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Study Arm, no competitor

Group Type: EXPERIMENTAL

OTSA101-DTPA-111In

Intervention Type: DRUG

single IV injection, 185MBq/body

OTSA101-DTPA-90Y

Intervention Type: DRUG

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

Interventions

OTSA101-DTPA-111In

single IV injection, 185MBq/body

Intervention Type: DRUG

OTSA101-DTPA-90Y

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OncoTherapy Science, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Osaka International Cancer Institute

Osaka, , Japan

Cancer Institute Hospital of JFCR

Tokyo, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Countries

Japan

Other Identifiers

OTS3050102

Identifier Type: -

Identifier Source: org_study_id