Relapsed or Refractory Synovial Sarcoma
Conditions
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.
Interventions
DRUGOTSA101-DTPA-111In
single IV injection, 185MBq/body
DRUGOTSA101-DTPA-90Y
IV injection (max. 3 injections per patient), 1110MBq/body
Sponsors
OncoTherapy Science, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) and Biodistribution of OTSA101-DTPA-111In | 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 | 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 | 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. |
Countries
Japan
Outcome results
None listed