Reference Detail

Request Content

Contact

Missing content? – Request curation!

Request curation for specific Genes, Variants, or PubMed publications.

Have questions, comments, or suggestions? - Let us know!

Email us at : ckbsupport@genomenon.com

Ref Type Journal Article
PMID (38295954)
Authors Shi Y, Hu X, Li X, Gong C, Wang K, Li Y, Zhang S, Luo Y, Wang P, Jiang L, Meng X, Dong X, Wang H, Yang R, Mei Q, Liu B, Yang L, Sun Y
Title Ficonalkib (SY-3505) in Advanced ALK-Positive Non-Small-Cell Lung Cancer: A Multicenter, Open-Label, Single-Arm, Phase I/Ⅱ Study.
Journal Vol Issue Date Pages Journal Short Title
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 2024 Jan 29 J Thorac Oncol
URL
Abstract Text Treatment options for second-generation (2nd-gen) anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) resistant patients are limited. We evaluated the safety, pharmacokinetics, and efficacy of ficonalkib (SY-3505), a third-generation (3rd-gen) ALK TKI.This first-in-human, phase I/Ⅱ study (Chinese Clinical Trial Registry identifier: ChiCTR1900025619; ClinicalTrials.gov identifier: NCT05257512) had two parts. Phase I included a dose-escalation phase (25-800 mg quaque die [QD]) and a dose-expansion phase (500 mg QD or 600 mg QD). Phase Ⅱ enrolled patients treated at recommended phase Ⅱ dose (RP2D). Primary endpoints were safety in phase I and objective response rate (ORR) in phase Ⅱ.Between Apr 21, 2020, and Aug 31, 2023, a total of 127 patients were enrolled, with 62 in phase I. Ficonalkib was well absorbed and tolerated, with one dose limited toxicity event occurring at 800 mg QD. Treatment-related adverse events (TRAEs) occurred in 85.5% of patients, with 19.4% experienced ≥ grade 3 events. The ORR was 38.3% (23/60, 95% confidence interval [CI] 26.1-51.8%) in phase I, and 600 mg QD was established as RP2D. In phase Ⅱ, a total of 65 patients received ficonalkib at 600 mg QD. Totally 88 patients received ficonalkib at 600 mg QD in phase I/Ⅱ, and all had received prior 2nd-gen ALK TKI treatment. 90.9% of patients experienced TRAEs and 14.8% experienced ≥ grade 3 events. The ORR in efficacy-evaluable patients received ficonalkib at 600 mg QD was 47.5% (38/80, 95% CI 36.2-59.0%), with an intracranial ORR of 37.5% (12/32, 95% CI 21.1-56.3%) in these patients with measurable brain lesions at baseline.Ficonalkib (SY-3505) was well tolerated, with favorable safety profiles and promising efficacy in patients resistant to prior 2nd-gen ALK TKI.

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.