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

  • STATUS
    Recruiting
  • days left to enroll
    16
  • participants needed
    20
  • sponsor
    OncoTherapy Science, Inc.
Updated on 16 October 2022

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.

Details
Condition Relapsed or Refractory Synovial Sarcoma
Treatment OTSA101-DTPA-111In, OTSA101-DTPA-90Y
Clinical Study IdentifierNCT04176016
SponsorOncoTherapy Science, Inc.
Last Modified on16 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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