A phase 1/2 study of DTX-SPL8783 in advanced solid tumours or in NSCLC

• Research type

  Research Study

• Full title

  A phase 1/2 dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) as monotherapy in patients with advanced solid tumours or in combination with nintedanib in patients with non-small cell lung cancer (NSCLC).”

• IRAS ID

  204296

• Contact name

  James Spicer

• Contact email

  james.spicer@kcl.ac.uk

• Sponsor organisation

  Starpharma Pty Ltd

• Eudract number

  2016-000877-19

• Duration of Study in the UK

  0 years, 10 months, 30 days

• Research summary

  This is a standard phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of DTXSPL8783
  (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours. This open-label study is
  divided into two phases; (i) dose escalation and (ii) dose expansion phase to confirm the recommended Phase II
  dose.
  The primary objective is to establish the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of DTXSPL8783
  given intravenously (IV). The secondary objectives is to characterise the safety and tolerability profile of DTXSPL8783
  in patients with advanced cancer; to characterise the pharmacokinetics (PK) of DTX-SPL8783; to define a
  recommended dose for phase 2 studies of DTX-SPL8783 dosed IV and to explore preliminary anti-tumour efficacy.
  Assuming that conversion to standard dose escalation occurs at dose-level 5 and the MTD is dose-level 6, then a
  minimum of 13 patients will be enrolled during dose escalation. Up to an additional 10 patients will be enrolled during
  dose expansion for a total of 23 patients in the study overall.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  16/LO/0994

• Date of REC Opinion

  13 Jul 2016

• REC opinion

  Further Information Favourable Opinion