ZOvCa: A phase 1 PET-CT study to evaluate the safety, biodistribution and pharmacokinetics of 89Zr-hu/mo-10D7 in patients with advanced epithelial Ovarian Cancer

Mater Misericordiae Ltd0 个研究点目标入组 30 人开始时间: 2024年4月16日最近更新: 2024年6月24日

适应症

试验速览

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•Adults (equal or greater than 18 years) with recurrent, histologically proven advanced ovarian cancer.
•Macroscopically visible tumour on diagnostic CT with contrast and FDG-PET/CT imaging.
•CDCP1 expression proven on tumour sample.
•ECOG 0-1
•Expected survival more than 3 months
•Adequate organ function. Out of range values that are not clinically significant will be permitted, except for the following laboratory parameters, which must be within the ranges specified: Serum AST and ALT (acceptable range less than or equal to 2.5 x ULN) and Serum bilirubin (acceptable range less than or equal to 1.5 x ULN)

•Use of anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, or any investigational therapy within 28 days prior to administration of 89Zr-hu/mo-10D7.
•History of major immunologic reaction to any IgG containing agent.
•Medical condition(s) which places the subject at an unacceptably high risk.
•Subject is pregnant, lactating, or unwilling/unable to use adequate contraception.

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