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
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|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Refractory Synovial Sarcoma||Drug: OTSA101-DTPA-111In Drug: OTSA101-DTPA-90Y||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Single Study Arm, no competitor||
single IV injection, 185MBq/body
IV injection (max. 3 injections per patient), 1110MBq/body
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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
|Contact: OncoTherapy Sciencefirstname.lastname@example.org|
|Osaka International Cancer Institute||Recruiting|
|Contact: Satoshi Takenaka, M.D. See Central Contact|
|Cancer Institute Hospital of JFCR||Recruiting|
|Contact: Keisuke Ae, M.D.|
|National Cancer Center Hospital||Recruiting|
|Contact: Kan Yonemori, M.D See Central Contact|
|Responsible Party:||OncoTherapy Science, Inc.|
|Other Study ID Numbers:||
|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|
|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|
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