Phase I, first-in-human Thorium-227 study in patients with MCRPC

• Research type

  Research Study

• Full title

  A Phase 1, open-label, first-in-human, multi-center, study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of a thorium-227 labeled antibody-chelator conjugate, BAY 2315497 Injection, in patients with metastatic castration resistant prostate cancer

• IRAS ID

  247618

• Contact name

  Johann de Bono

• Contact email

  johann.de-bono@icr.ac.uk

• Eudract number

  2018-001490-25

• Duration of Study in the UK

  3 years, 11 months, 5 days

• Research summary

  Summary of Research
  The primary objective of this study is to determine the safety and tolerability profile, maximum tolerated dose (MTD) or maximum feasible dose of BAY 2315497 injection in patients with metastatic castration resistant prostate cancer (mCRPC)

  Summary of Results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.bayer.com%252Fstudy%252F19445%2FNBTI%2FGiXCAQ%2FAQ%2F1322d61f-bee6-4a83-a7ad-17d4f7bc4a09%2F1%2FKGpxe4eYjZ&data=05%7C02%7Cchelsea.rec%40hra.nhs.uk%7C04a33ed07d694eb0f9e908de3f095159%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639017506422907762%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=Yq6hee5rKT4wkBzhmCzoAgW%2B0G7gWklDmctD0W8TlZU%3D&reserved=0

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  18/LO/1600

• Date of REC Opinion

  12 Dec 2018

• REC opinion

  Further Information Favourable Opinion