An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma - MORAb-009 in patients with mesothelioma

Morphotek Inc0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- >= 18 years of age
•- Life expectancy of at least 3 months
•- Confirmed diagnosis of MPM with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); or epithelial type or biphasic (mixed) type with low sarcomatous content).
•- Measurable disease at Screening
•- Karnofsky performance status of >= 70% at Screening
•- Other significant medical conditions must be well-controlled and stable
•- Laboratory results must be within a certain range (see page 26)
•- serum creatinine clearance >= 60 mL/min
•- Subjects must be sterile or using adequate contraception during the study and for at least 8 weeks after the last dose of MORAb-009
•- willing and able to sign informed consent

•- Sarcomatous type of mesothelioma
•- Prior systemic therapy or radiotherapy
•- central nervous system (CNS) tumor involvement
•- other active malignancy requiring treatment
•- clinically significant heart disease or arrhythmias
•- hepatitis or HIV infection
•- active serious systemic disease
•- Treatment within 3 months of the start of the trial with other immunomodulatory therapy
•- hypersensitivity to one of the medications which will be administered
•- breast-feeding, pregnant, or likely to become pregnant
•- not willing or unable to sign informed consent

发起方