A Phase 1 Study of Sl-901 in Patients with Advanced Solid Tumours

• Research type

  Research Study

• Full title

  A Phase I, open label, dose-escalation study of the PI3K inhibitor SL-901 in patients with advanced solid tumors.

• IRAS ID

  289189

• Contact name

  Deborah Norby

• Contact email

  DNorby@stemline.com

• Sponsor organisation

  Stemline Therapeutics, Inc

• Eudract number

  2019-004135-22

• Clinicaltrials.gov Identifier

  NCT05382936

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  2 years, 6 months, 0 days

• Research summary

  This study will enrol adult patients with advanced solid tumours for whom no effective standard therapy options are available.
  This study will include approximately 108 patients in 3 centres in the UK.
  The main purpose of the escalation part of the study is to find the highest dose of the investigational drug SL-901 that can be given to patients without causing severe side effects and evaluate if once daily or twice daily dosing is best. Each treatment cycle is 28 days long. The study will then be expanded and the chosen dose and schedule will be tested in groups of patients with specific genetic alterations that are more likely to derive benefit from treatment with the drug.

  Other objectives of the study are to understand how the body handles SL-901, called pharmacokinetics (PK), what SL-901 does to the body, called pharmacodynamics (PD) and to find out what effect SL-901 may have on cancer growth
  The results of this part of the study will be used to determine the best dose for future patients.
  Patients could be on this study as long as they are benefiting from the treatment. Overall study duration (including enrolling, treatment and evaluation) This will range from approximately 2 months to a maximum of about 2 years.

  Lay Summary of results

  Lay Summary for Study STML-901-0119 Stemline Therapeutics Inc. A Menarini Group Company (the study sponsor), on behalf of the Contract Research Organization TMC and its subcontractors, thanks all patients, site
  personnel and investigators for participating in the completed study: “A Phase 1, Open-label, Dose-escalation Study of the PI3K Inhibitor SL-901 in Patients with Advanced Solid Tumors”. The study took place in the United Kingdom between March 2021 to May 2023. The drug, SL-901, was used for the treatment of advanced solid tutors. SL-901 is an orally investigational anticancer drug aimed to treat patients whose cancers harbour an overactive PI3K signalling pathway. SL-901 can also be used in combination with other anticancer therapies in patients whose tumor resistance mechanisms to other therapies rely on signalling through the PI3K pathway (a complex cellular level enzyme signalling mechanism). The Phase 1 Open label, dose escalation ( finding the optimal maximum dosing for patients) was set up to investigate the safety, the mechanism, and the effects of the drug SL-901. SL-901 was administered orally twice daily and once daily in a 28-day treatment cycle. 3 to 6 patients were treated in each of the groups, one group receiving twice daily oral medication and one group receiving once daily oral medication. Drug does in each group started at 20mg groups and escalated to 80mg. 20 patients in total received SL 901 orally. Study results: Overall, a total of 5 of the 20 patients who were treated with SL 901 had stable disease and 12 had progressive disease and 1 was not evaluable. Disease control was reported for 5 patients. The most common side effects included nausea, diarrhoea, vomiting constipation, back pain and raised liver enzymes.
  Has the registry been updated to include summary results?
  No
  If no – why not?
  In line with publication of the abbreviated CSR planned for March 2024
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?
  Yes
  If yes, describe or provide URLs to disseminated materials
  None Specified in IRAS Q A51
  Have participants been informed of the results of the study?
  No
  If no, explain why they haven't
  Study was stopped early at 20 subjects enrolled due to sponsor business determined need.
  Have you enabled sharing of study data with others?
  No
  If no, explain why sharing hasn't been enabled
  Not applicable as per ICF for this study
  Have you enabled sharing of tissue samples and associated data with others?
  No
  If no, explain why
  Not applicable as per ICF for this study
  

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  20/LO/1235

• Date of REC Opinion

  7 Jan 2021

• REC opinion

  Further Information Favourable Opinion