A phase II study of antibody-drug conjugate, TAK-264 (MLN0264) in previously treated patients with advanced or metastatic pancreatic adenocarcinoma expressing guanylyl cyclase C

Investigational New Drugs
Khaldoun AlmhannaThea Kalebic

Abstract

Background This phase II open-label, multicenter study evaluated the efficacy, safety, and tolerability of TAK-264 in previously treated patients with advanced or metastatic pancreatic adenocarcinoma expressing guanylyl cyclase C (GCC). Methods Patients with advanced or metastatic pancreatic adenocarcinoma expressing GCC (H-score ≥ 10) received TAK-264 1.8 mg/kg on day 1 of a 21-day cycle as a 30-min intravenous infusion for up to 1 year or until disease progression or unacceptable toxicity. The primary objective was overall response rate (ORR [complete response + partial response (PR)]). Secondary objectives included evaluations of the safety and pharmacokinetic profile of TAK-264 (NCT02202785). Results 43 patients were enrolled and treated with 1.8 mg/kg TAK-264: 11, 15, and 17 patients with low, intermediate, and high GCC expression, respectively. Median number of treatment cycles received was two (range 1-10). The ORR was 3%, including one patient with intermediate GCC expression who achieved a PR. All patients experienced ≥1 adverse events (AE). The majority of patients experienced grade 1/2 AEs affecting the gastrointestinal tract. Fifteen (35%) patients experienced ≥grade 3 drug-related AEs; five (12%) patients had a ser...Continue Reading

Associated Clinical Trials

References

Dec 1, 1994·Gastroenterology·S L CarrithersS A Waldman
Feb 1, 1996·Diseases of the Colon and Rectum·S L CarrithersS A Waldman
Dec 10, 1996·Proceedings of the National Academy of Sciences of the United States of America·S L CarrithersS A Waldman
May 28, 2005·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·E BucD Pezet
Mar 28, 2008·Scandinavian Journal of Gastroenterology·Oliver KloetersHasan Kulaksiz
Dec 23, 2008·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·E A EisenhauerJ Verweij
Nov 5, 2010·The New England Journal of Medicine·Anas YounesAndres Forero-Torres
May 13, 2011·The New England Journal of Medicine·Thierry ConroyUNKNOWN PRODIGE Intergroup
Mar 1, 2010·Therapeutic Advances in Medical Oncology·Ben Lawrence, Michael Findlay
Sep 9, 2011·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Celalettin CamciAbdullah T Demiryürek
Feb 8, 2013·Biomarkers in Medicine·Terry Hyslop, Scott A Waldman
Oct 18, 2013·The New England Journal of Medicine·Daniel D Von HoffMarkus F Renschler
Nov 19, 2013·Drug Discovery Today·Heidi L PerezRobert M Borzilleri
Jul 17, 2015·Bioscience Reports·Christina Peters, Stuart Brown
Nov 5, 2015·Biomolecules & Therapeutics·Eunhee G Kim, Kristine M Kim
Jan 8, 2016·British Journal of Cancer·Nikolaos Diamantis, Udai Banerji
May 15, 2016·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Khaldoun AlmhannaJordi Rodon
Oct 16, 2016·Protein & Cell·Kyoji Tsuchikama, Zhiqiang An

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Citations

Oct 26, 2018·Expert Opinion on Investigational Drugs·Alexis D LealWells A Messersmith
Jan 14, 2018·Journal of Hematology & Oncology·Julian A Marin-AcevedoYanyan Lou
Sep 19, 2020·Expert Review of Clinical Pharmacology·Jeffrey A Rappaport, Scott A Waldman
Jan 21, 2021·Biomarkers in Medicine·John C FlickingerScott A Waldman
May 25, 2021·Expert Review of Precision Medicine and Drug Development·Amanda N LisbyScott A Waldman
Jun 1, 2021·Expert Opinion on Therapeutic Targets·Ariana A EntezariScott A Waldman
Jun 26, 2021·Pharmacology & Therapeutics·Yiming JinAndrew J Wiemer
Oct 30, 2018·Analytical Chemistry·Hiroshi SugimotoMark G Qian

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