The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body & inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.

开始日期2010-12-01

申办/合作机构

Memorial Sloan Kettering Cancer Center

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100 项与 124I-PUH-71 相关的临床结果

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100 项与 124I-PUH-71 相关的转化医学

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100 项与 124I-PUH-71 相关的专利（医药）

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项与 124I-PUH-71 相关的文献（医药）

2020-10-01·Clinical cancer research : an official journal of the American Association for Cancer Research

First-in-Human Trial of Epichaperome-Targeted PET in Patients with Cancer

Article

作者: Zatorska, Danuta ; Zhang, Hanwen ; Modi, Shanu ; Bromberg, Jacqueline ; Larson, Steven M. ; Fox, Josef J. ; Jhaveri, Komal ; Zanzonico, Pat B. ; Ochiana, Stefan O. ; Dunphy, Mark P.S. ; Schöder, Heiko M. ; Pillarsetty, Nagavarakishore ; Beattie, Bradley J. ; Lewis, Jason S. ; Uddin, Mohammad M. ; Burnazi, Eva M. ; Taldone, Tony ; Pressl, Christina ; Grkovski, Milan ; Hudis, Clifford A. ; Norton, Larry ; Chiosis, Gabriela ; Lyashchenko, Serge K.

Abstract:

Purpose::

124I-PU-H71 is an investigational first-in-class radiologic agent specific for imaging tumor epichaperome formations. The intracellular epichaperome forms under cellular stress and is a clinically validated oncotherapeutic target. We conducted a first-in-human study of microdose 124I-PU-H71 for PET to study in vivo biodistribution, pharmacokinetics, metabolism, and safety; and the feasibility of epichaperome-targeted tumor imaging.

Experimental Design::

Adult patients with cancer (n = 30) received 124I-PU-H71 tracer (201±12 MBq, <25 μg) intravenous bolus followed by PET/CT scans and blood radioassays.

Results::

124I-PU-H71 PET detected tumors of different cancer types (breast, lymphoma, neuroblastoma, genitourinary, gynecologic, sarcoma, and pancreas). 124I-PU-H71 was retained by tumors for several days while it cleared rapidly from bones, healthy soft tissues, and blood. Radiation dosimetry is favorable and patients suffered no adverse effects.

Conclusions::

Our first-in-human results demonstrate the safety and feasibility of noninvasive in vivo detection of tumor epichaperomes using 124I-PU-H71 PET, supporting clinical development of PU-H71 and other epichaperome-targeted therapeutics.

100 项与 124I-PUH-71 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
骨髓肿瘤	临床1期	美国	Memorial Sloan Kettering Cancer Center	2010-12-01
骨髓肿瘤	临床1期	美国	Samus Therapeutics LLC初创企业	2010-12-01
非霍奇金淋巴瘤	临床1期	美国	Memorial Sloan Kettering Cancer Center	2010-12-01
非霍奇金淋巴瘤	临床1期	美国	Samus Therapeutics LLC初创企业	2010-12-01
肿瘤	临床1期	美国	-	-
肿瘤	临床1期	-	Memorial Sloan Kettering Cancer Center	-
肿瘤	临床1期	-	Samus Therapeutics LLC初创企业	-