Phase-1 dose escalation & expansion in advanced solid tumours

• Research type

  Research Study

• Full title

  An open-label, phase 1, first-in-human, dose escalation and expansion study to evaluate the safety, tolerability, maximum tolerated or administered dose, pharmacokinetics, pharmacodynamics and tumor response profile of the Aryl Hydrocarbon Receptor inhibitor (AhRi) BAY 2416964 in participants with advanced solid tumors

• IRAS ID

  269499

• Contact name

  Juanita Lopez

• Contact email

  juanita.lopez@icr.ac.uk

• Sponsor organisation

  Bayer AG

• Eudract number

  2019-000722-22

• Duration of Study in the UK

  3 years, 11 months, 18 days

• Research summary

  Research Summary
  In this study researchers want to gather relevant information regarding the safety of BAY2416964 and how well the drug works in participants with a type of solid tumors that cannot be cured by currently available drugs. Researchers want to find the highest dose of BAY2416964 that participants could take without having too many side effects, how the drug is tolerated and the way the body absorbs, distributes and gets rid of the study drug. BAY 2416964 is a small molecule which blocks the Aryl
  Hydrocarbon Receptor (a protein involved in immune cell reaction to tumour cells) allowing the body to use its immune response against the tumour cells.

  Summary of results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.bayer.com%252Fstudies%252F%253FKeyword%253D20201%2526Latitude%253D%2526Longitude%253D%2526LocationName%253D%2526MileRadius%253D%2526page%253D0%2526SortField%253DLocation_Distance%2526SortOrder%253Dasc%2526Status%253D%2526ageRange%253D%2526conditions%253D%2526phases%253D%2526gender%253D%2526healthyVol%253D%2526studyType%253D%2526studyResult%253D%2526locationCountryInternal%253D%2526biomarkers%253D%2526IsFlexibleTrial%253D%2FNBTI%2F-CG7AQ%2FAQ%2F7c9fb81f-3f37-4ae1-b074-a6dc4e22e71c%2F3%2FE5RETXPqt9&data=05%7C02%7Cchelsea.rec%40hra.nhs.uk%7Cd401c237f7a848fb729008dd4442fa63%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638741776639952290%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=zL9L%2BFSlMrOA9PrxT6kHf8zGXJIDy3yGPpPLZRnk4wM%3D&reserved=0

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  19/LO/1709

• Date of REC Opinion

  13 Dec 2019

• REC opinion

  Further Information Favourable Opinion