The purpose of this study is to see how well the experimental imaging agent 89Zr-DFO-HuMab-5B1 attaches to pancreatic tumors, and to find out whether PET/CT scans done with this imaging agent produce better images of cancer.

开始日期2021-05-10

申办/合作机构

Memorial Sloan Kettering Cancer Center

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NCT02687230 / Terminated临床1期

Phase 1 Study of 89Zr-DFO-HuMab-5B1 (MVT-2163) With HuMab-5B1 (MVT-5873) in Patients With Pancreatic Cancer or Other CA19-9 Positive Malignancies

Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and dose of these agents that result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for imaging and a clinical assessment. The last study visit is on day 28.

开始日期2016-07-11

申办/合作机构

BioNTech Research & Development, Inc.

[+1]

100 项与 89Zr-HuMab 5B1 相关的临床结果

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100 项与 89Zr-HuMab 5B1 相关的转化医学

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100 项与 89Zr-HuMab 5B1 相关的专利（医药）

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项与 89Zr-HuMab 5B1 相关的文献（医药）

2019-12-01·Clinical Cancer Research1区 · 医学

Retooling a Blood-Based Biomarker: Phase I Assessment of the High-Affinity CA19-9 Antibody HuMab-5B1 for Immuno-PET Imaging of Pancreatic Cancer

1区 · 医学

Article

作者: Pandit-Taskar, Neeta ; Scholz, Wolfgang ; Maffuid, Paul W. ; O'Reilly, Eileen M. ; Lewis, Jason S. ; O'Donoghue, Joseph A. ; Teng, Rebecca ; Lyashchenko, Serge K. ; Lohrmann, Christian ; Ruan, Shutian ; Carrasquillo, Jorge A. ; Weber, Wolfgang A.

AbstractPurpose:In patients with cancer who have an abnormal biomarker finding, the source of the biomarker in the bloodstream must be located for confirmation of diagnosis, staging, and therapy planning. We evaluated if immuno-PET with the radiolabeled high-affinity antibody HuMab-5B1 (MVT-2163), binding to the cancer antigen CA19-9, can identify the source of elevated biomarkers in patients with pancreatic cancer.Patients and Methods:In this phase I dose-escalating study, 12 patients with CA19-9–positive metastatic malignancies were injected with MVT-2163. Within 7 days, all patients underwent a total of four whole-body PET/CT scans. A diagnostic CT scan was performed prior to injection of MVT-2163 to correlate findings on MVT-2163 PET/CT.Results:Immuno-PET with MVT-2163 was safe and visualized known primary tumors and metastases with high contrast. In addition, radiotracer uptake was not only observed in metastases known from conventional CT, but also seen in subcentimeter lymph nodes located in typical metastatic sites of pancreatic cancer, which were not abnormal on routine clinical imaging studies. A significant fraction of the patients demonstrated very high and, over time, increased uptake of MVT-2163 in tumor tissue, suggesting that HuMab-5B1 labeled with beta-emitting radioisotopes may have the potential to deliver therapeutic doses of radiation to cancer cells.Conclusions:Our study shows that the tumor antigen CA19-9 secreted to the circulation can be used for sensitive detection of primary tumors and metastatic disease by immuno-PET. This significantly broadens the number of molecular targets that can be used for PET imaging and offers new opportunities for noninvasive characterization of tumors in patients.

100 项与 89Zr-HuMab 5B1 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
小细胞肺癌	临床2期	美国	-	2018-12-31
膀胱癌	临床2期	美国	-	2018-12-11
胰腺癌	临床1期	-	Memorial Sloan Kettering Cancer Center	-
胰腺癌	临床1期	-	MabVax Therapeutics, Inc.	-
结直肠癌	药物发现	美国	-	2019-01-26
胰腺腺泡癌	药物发现	美国	BioNTech Research & Development, Inc.	2016-07-11

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


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