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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04176016
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
OncoTherapy Science, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Synovial Sarcoma Drug: OTSA101-DTPA-111In Drug: OTSA101-DTPA-90Y Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In [ Time Frame: up to 72 hours post dosing ]
    Concentration of OTSA101-DTPA in plasma and the distribution of OTSA101-DTPA in the body by imaging scan will be assessed.

  2. Safety of OTSA101-DTPA-111In [ Time Frame: up to 10 days post dosing ]
    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.

  3. Safety of OTSA101-DTPA-90Y [ Time Frame: up to 6 weeks post dosing ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176016


Contacts
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Contact: OncoTherapy Science +81-44-201-6429 info@oncotherapy.co.jp

Locations
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Japan
Osaka International Cancer Institute Recruiting
Osaka, Japan
Contact: Satoshi Takenaka, M.D.    See Central Contact      
Cancer Institute Hospital of JFCR Recruiting
Tokyo, Japan
Contact: Keisuke Ae, M.D.         
National Cancer Center Hospital Recruiting
Tokyo, Japan
Contact: Kan Yonemori, M.D    See Central Contact      
Sponsors and Collaborators
OncoTherapy Science, Inc.
More Information
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Responsible Party: OncoTherapy Science, Inc.
ClinicalTrials.gov Identifier: NCT04176016    
Other Study ID Numbers: OTS3050102
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Sarcoma
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Edetic Acid
Pentetic Acid
Antidotes
 Protective Agents
Physiological Effects of Drugs
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Anticoagulants
Calcium Chelating Agents