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000170408 0247_ $$2ISSN$$a1557-3265
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000170408 1001_ $$00000-0003-3907-5918$$aHajda, Jacek$$b0
000170408 245__ $$aPhase 2 trial of oncolytic H-1 parvovirus therapy shows safety and immune cell activity in patients with metastatic pancreatic ductal adenocarcinoma.
000170408 260__ $$aPhiladelphia, Pa. [u.a.]$$bAACR$$c2021
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000170408 500__ $$a2021 Oct 15;27(20):5546-5556 / #LA:F230#
000170408 520__ $$aTo investigate safety, clinical efficacy, virus pharmacokinetics, shedding and immune response after administration of an oncolytic parvovirus (H-1PV, ParvOryx) to patients with metastatic pancreatic ductal adenocarcinoma (PDAC) refractory to first-line therapy.This is a non-controlled, single arm, open label, dose-escalating, single center clinical trial. Seven patients with PDAC and at least one liver metastasis were included. ParvOryx was administered intravenously on four consecutive days and as intralesional injection, six to thirteen days thereafter. Altogether, three escalating dose levels were investigated. In addition, gemcitabine treatment was initiated on day 28.ParvOryx showed excellent tolerability with no dose-limiting toxicities. One patient had confirmed partial response (PR) and one patient revealed unconfirmed PR according to RECIST criteria. Both patients showed remarkably long surivial of 326 and 555 days, respectively. Investigation of pharmacokinetics and virus shedding revealed dose-dependency with no excretion of active virus particles in saliva or urine and very limited excretion in feces. H-1PV nucleic acids were detected in tumor samples of four patients. All patients showed T cell responses to viral proteins. An interesting immunological pattern developed in tumor tissues and in blood of both patients with partial response suggesting immune activation after administration of ParvOryx.The trial met all primary objectives, revealed no environmental risks and indicated favorable immune modulation after administration of ParvOryx. It can be considered a good basis for further systematic clinical development alone or in combination with immunomodulatory compounds.
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000170408 7001_ $$0P:(DE-He78)119d7d540a0e6fc5734898bef4866d7f$$aLeuchs, Barbara$$b1
000170408 7001_ $$0P:(DE-He78)34bd069ab74ead9ac824c1e0896ecbf0$$aAngelova, Assia L$$b2
000170408 7001_ $$0P:(DE-He78)0ee3163b1149540612c1397430e616d5$$aFrehtman, Veronika$$b3
000170408 7001_ $$0P:(DE-He78)2d7958ea507b0b738619074b38ec6d54$$aRommelaere, Jean$$b4
000170408 7001_ $$aMertens, Mieke$$b5
000170408 7001_ $$aPilz, Maximilian$$b6
000170408 7001_ $$00000-0003-2402-4333$$aKieser, Meinhard$$b7
000170408 7001_ $$aKrebs, Ottheinz$$b8
000170408 7001_ $$aHuber, Bernard$$b9
000170408 7001_ $$0P:(DE-He78)26712fbb7710e2e6ea9de830306ce125$$aEngeland, Christine$$b10
000170408 7001_ $$aMavratzas, Athanasios$$b11
000170408 7001_ $$aHohmann, Nicolas$$b12
000170408 7001_ $$0P:(DE-He78)edf4ac49d96e94a490fec5095e9fe769$$aSchreiber, Jutta$$b13
000170408 7001_ $$aJäger, Dirk$$b14
000170408 7001_ $$0P:(DE-He78)0a4053be7ffd6aa9bef69de28753a601$$aHalama, Niels$$b15
000170408 7001_ $$0P:(DE-He78)82090937e7b88ac8ec70bbc40ad6b512$$aSedlaczek, Oliver$$b16
000170408 7001_ $$aGaida, Matthias M$$b17
000170408 7001_ $$00000-0001-8345-1031$$aDaniel, Volker$$b18
000170408 7001_ $$aSpringfeld, Christoph$$b19
000170408 7001_ $$0P:(DE-He78)833f90e2abdd29594ad5c4f08600f191$$aUngerechts, Guy$$b20$$eLast author
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