A Phase I Study of Radiolabeled (111In or 90Y) OTSA101-DTPA for relapsed/refractory synovial sarcoma

OncoTherapy Science, Inc.0 个研究点目标入组 20 人开始时间: 2019年11月22日最近更新: 2024年5月27日

适应症

试验速览

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•Patients have been diagnosed with synovial sarcoma.
•Synovial sarcoma is recurrent or refractory.
•Patients were previously treated with standard chemotherapy.
•ECOG PS is between 0 and 1.
•Patients have one or more measurable lesions on contrast-enhanced CT.
•More than 28 days have passed since prior treatment.
•The results of pre-registration tests meet the criteria.
•Consent to use contraception for a certain period of time after obtaining informed consent and after the final administration of the study drug.
•Written consent has been obtained for participation in this study.

•Patients have double cancers.
•Patients have clinical symptoms associated with brain metastases.
•Patients with any infection requiring systemic treatment.
•Patients have concurrent or history of apparent pneumonitis or pulmonary fibrosis.
•Patients have a history or complication of severe hypersensitivity reactions to antibody or human serum albumin preparations.
•Patients have a history or comorbid autoimmune diseases.
•Patients have a history of myocardial infarction prior to enrollment.
•Patients have uncontrolled diabetes, hypertension, and other ailments.
•Patients require systemic steroids or immunosuppressants.
•Patients are HIV, HTLV-1 or HCV antibody-positive by pre-enrolment testing.
•Patients are HBsAg-positive on pre-enrolment testing.
•Female patients are pregnant, lactating or may be pregnant.
•Patients are participating in other clinical trials.
•Patients are judged to be difficult to participate in other clinical trials.

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