A phase II study assessing the safety and efficacy of ASP1650 in male patients with relapsed refractory germ cell tumors.
ASP1650
Germ cell tumor
Testicular cancer
Journal
Investigational new drugs
ISSN: 1573-0646
Titre abrégé: Invest New Drugs
Pays: United States
ID NLM: 8309330
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
28
03
2022
accepted:
21
06
2022
pubmed:
28
6
2022
medline:
25
8
2022
entrez:
27
6
2022
Statut:
ppublish
Résumé
Claudin6(CLDN6) is a tight junction protein of claudin-tetraspanin family and is of the earliest molecules expressed in embryonic epithelium. CLDN6 is frequently aberrantly expressed in testicular germ-cell tumors(GCT). ASP1650 is a chimeric-mouse/human-IgG1 antibody directed against CLDN6. Two-part, open-label, phase-II trial investigating ASP1650 in patients with relapsed/refractory GCT and no curable options. Part1 was a safety lead-in to establish the recommended-phase-II-dose(RP2D). Part2 was a phase-II study designed to evaluate the antitumor effects of ASP1650. CLDN6 expression was centrally assessed on archival tumor tissue using immunohistochemistry. The primary objectives were to establish the RP2D(safety lead-in) and the antitumor activity(phase-II) of ASP1650. Nineteen male patients were enrolled: 6 patients in 1000 mg/m
Identifiants
pubmed: 35759134
doi: 10.1007/s10637-022-01276-w
pii: 10.1007/s10637-022-01276-w
pmc: PMC10207925
mid: NIHMS1896392
doi:
Substances chimiques
Antibodies, Monoclonal
0
Antineoplastic Agents
0
Banques de données
ClinicalTrials.gov
['NCT03760081']
Types de publication
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1087-1094Subventions
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
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