Safety and efficacy of CDX-014, an antibody-drug conjugate directed against T cell immunoglobulin mucin-1 in advanced renal cell carcinoma View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-05-29

AUTHORS

Bradley A. McGregor, Michael Gordon, Ronan Flippot, Neeraj Agarwal, Saby George, David I. Quinn, Mark Rogalski, Thomas Hawthorne, Tibor Keler, Toni K. Choueiri

ABSTRACT

CDX-014 is an antibody-drug conjugate directed against TIM-1, a surface marker highly expressed in renal cell carcinoma (RCC) and ovarian carcinoma. This phase I, first-in-human trial was conducted to evaluate the safety and preliminary activity of CDX-014 in patients with advanced refractory RCC, following a dose-escalation and dose expansion design. CDX-014 was administered intravenously at doses ranging from 0.15 to 2.0 mg/kg every 2 or 3 weeks until progression or unacceptable toxicity. Sixteen patients received at least one dose of CDX-014. The maximum tolerated dose was not identified. Most frequent adverse grade 1 or 2 adverse events included nausea (38%), fatigue, alopecia, elevation of AST and decreased appetite (25% each). Adverse events of grade 3 or more included hyperglycemia (19%), urosepsis (6%), and one multi-organ failure (6%) responsible for one treatment-related death. Two patients discontinued therapy for adverse events including fatigue grade 2 and urosepsis grade 4. CDX-014 showed antitumor activity with one prolonged partial response and a clinical benefit rate (objective response or stable disease >6 months) of 31%. The two patients that exhibited the most marked tumor shrinkage had high TIM-1 expression on tumor tissue. Overall, CDX-014 exhibited a manageable toxicity profile and early signs of activity, supporting further evaluation of antibody-drug conjugates in patients with advanced RCC and potentially other TIM-1 expressing cancers. Trial registrationhttps://clinicaltrials.gov/ct2/show/NCT02837991 NCT02837991; July 20, 2016. More... »

PAGES

1807-1814

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10637-020-00945-y

DOI

http://dx.doi.org/10.1007/s10637-020-00945-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1128024537

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/32472319


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