Actuate 1902:9-ING-41 alone/with chemotherapy in paediatrics

• Research type

  Research Study

• Full title

  Actuate 1902: Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK - 3β) Inhibitor, as a Single Agent or with Irinotecan, Temozolomide/Irinotecan or Cyclophosphamide/Topotecan in Pediatric Patients with Refractory Malignancies

• IRAS ID

  302657

• Contact name

  Juliet Gray

• Contact email

  jcgray@soton.ac.uk

• Sponsor organisation

  Actuate Therapeutics

• Eudract number

  2021-003552-17

• Clinicaltrials.gov Identifier

  NCT04239092

• Duration of Study in the UK

  2 years, 0 months, 0 days

• Research summary

  The study is for paediatric patients with refractory malignancies, which is cancer that does not respond to treatment, (because the tumour cells are resistant or because other drugs' side effects are too difficult to tolerate).
  This research study involves giving patients an investigational drug called 9-ING-41, either by itself or together as a combination with irinotecan which is usually used in chemotherapy, to see what the maximum tolerated dose of this treatment would be. The research study also involves looking at the toxicity of 9-ING-41 when given in combination with temozolomide/irinotecan, and cyclophosphamide/topotecan, which are also chemotherapy agents. 9-ING-41 stops an enzyme called GSK-3β from working
  in cancer cells. GSK-3β helps cancer cells to grow and to become resistant to chemotherapy drugs. We are running this study to see if by stopping the activity of
  GSK-3β using 9 ING-41, will kill the cancer cells and reduce tumour growth. The research study will also investigate whether when chemotherapy agents are administered combined with 9-ING-41 whether the treatment responds better, than with the chemotherapy agent alone.
  Patients will be given 9-ING-41 twice a week via intravenous infusion on days 1 and 4 with a cycle length of 21 days. When 9-ING-41 is given in combination with Irinotecan, Irinotecan will be administered on days 1 to 5 every 21 days. This dosing schedule is the same when 9-ING-41 is given in combination with Temozolomide and Irinotecan. When 9-ING-41 is given in combination with Cyclophosphamide and Topotecan , 9-ING-41 is given on day 2 and 5 of each cycle.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  21/LO/0816

• Date of REC Opinion

  3 Feb 2022

• REC opinion

  Further Information Favourable Opinion