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

Primary Purpose

Relapsed or Refractory Synovial Sarcoma

Status
Recruiting
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
OTSA101-DTPA-111In
OTSA101-DTPA-90Y
Sponsored by
OncoTherapy Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Synovial Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Osaka International Cancer InstituteRecruiting
  • Cancer Institute Hospital of JFCRRecruiting
  • National Cancer Center HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Study Arm, no competitor

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 20, 2019
Last Updated
January 18, 2023
Sponsor
OncoTherapy Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04176016
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OncoTherapy Science, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Synovial Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Study Arm, no competitor
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OTSA101-DTPA-111In
Intervention Description
single IV injection, 185MBq/body
Intervention Type
Drug
Intervention Name(s)
OTSA101-DTPA-90Y
Intervention Description
IV injection (max. 3 injections per patient), 1110MBq/body
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In
Description
Concentration of OTSA101-DTPA in plasma and the distribution of OTSA101-DTPA in the body by imaging scan will be assessed.
Time Frame
up to 72 hours post dosing
Title
Safety of OTSA101-DTPA-111In
Description
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.
Time Frame
up to 10 days post dosing
Title
Safety of OTSA101-DTPA-90Y
Description
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.
Time Frame
up to 6 weeks post dosing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
OncoTherapy Science
Phone
+81-44-201-6429
Email
info@oncotherapy.co.jp
Facility Information:
Facility Name
Osaka International Cancer Institute
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satoshi Takenaka, M.D.
Phone
See Central Contact
Facility Name
Cancer Institute Hospital of JFCR
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keisuke Ae, M.D.
Facility Name
National Cancer Center Hospital
City
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kan Yonemori, M.D
Phone
See Central Contact

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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