Anti- mesothelin expression tumor activity of thorium-227 antibody

• Research type

  Research Study

• Full title

  An 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 2287411 Injection, in patients with solid tumors known to express mesothelin

• IRAS ID

  240486

• Contact name

  Johann DeBono

• Contact email

  Johann.De-Bono@icr.ac.uk

• Sponsor organisation

  Bayer AG

• Eudract number

  2017-004052-29

• Duration of Study in the UK

  3 years, 9 months, 3 days

• Research summary

  The primary objective of this study is, to determine the safety, tolerability, maximum tolerated dose (MTD) or maximum feasible dose of BAY2287411 injection in patients with epithelioid malignant mesothelioma and serous ovarian cancer

  Lay Summary of Results

  A full Lay synopsis of the study results can be found at the following link:

  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.bayer.com%252Fstudy%252F%253Fid%253D18795%2FNBTI%2FAjy4AQ%2FAQ%2F4e748c70-295d-437d-9950-c862be0bb164%2F1%2FT2dvOvzAfm&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C69a88413b7434d8b18e608dcdc9bcb68%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627808890221206%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=KmqZNs2UcAEDf%2BKk4v%2Fw%2FZu8OW5hqYBkHInQNblD%2B2c%3D&reserved=0
  Has the registry been updated to include summary results?: Yes
  If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.bayer.com%252Fstudy%252F18795%252F%2FNBTI%2FAjy4AQ%2FAQ%2F4e748c70-295d-437d-9950-c862be0bb164%2F2%2F_6h-rgFjA9&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C69a88413b7434d8b18e608dcdc9bcb68%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627808890272218%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=C3cTKVFa6kZxCFw0bSfPG891%2BEmP%2F10%2BnDFYOtrKnJ8%3D&reserved=0
  If no – why not?:
  Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
  If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.bayer.com%252Fstudy%252F18795%252F%2FNBTI%2FAjy4AQ%2FAQ%2F4e748c70-295d-437d-9950-c862be0bb164%2F2%2F_6h-rgFjA9&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C69a88413b7434d8b18e608dcdc9bcb68%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627808890308338%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=qBsdQEAZsgs3UkaFlk5pIn2G%2F6YS8k7BB99TE274%2BzI%3D&reserved=0
  If pending, date when dissemination is expected:
  If no, explain why you didn't follow it:
  Have participants been informed of the results of the study?: Yes
  If yes, describe and/or provide URLs to materials shared and how they were shared: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.bayer.com%252Fstudy%252F18795%252F%2FNBTI%2FAjy4AQ%2FAQ%2F4e748c70-295d-437d-9950-c862be0bb164%2F2%2F_6h-rgFjA9&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C69a88413b7434d8b18e608dcdc9bcb68%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627808890332978%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=a%2BNtbN8bMUqMwO9jS1eGCaICE%2BOhgdEmFouuu%2FEFUvw%3D&reserved=0
  If pending, date when feedback is expected:
  If no, explain why they haven't:
  Have you enabled sharing of study data with others?: No
  If yes, describe or provide URLs to how it has been shared: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.bayer.com%252Fstudy%252F18795%252F%2FNBTI%2FAjy4AQ%2FAQ%2F4e748c70-295d-437d-9950-c862be0bb164%2F2%2F_6h-rgFjA9&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C69a88413b7434d8b18e608dcdc9bcb68%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638627808890355891%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=lFIeDmgFP3esv5nMRfQZLoMD6vR4sG5bsBqaTdk3%2BF0%3D&reserved=0
  If no, explain why sharing hasn't been enabled: EMA Full Dataset Results were submitted on 15-Mar-2023
  EMA Full Dataset results will not be made public but are available to National Competent Authority according to European Commission guide, since this is a Phase I trial conducted in adult population

  Have you enabled sharing of tissue samples and associated data with others?: No
  If yes, describe or provide a URL:
  If no, explain why: EMA Full Dataset Results were submitted on 15-Mar-2023
  EMA Full Dataset results will not be made public but are available to National Competent Authority according to European Commission guide, since this is a Phase I trial conducted in adult population

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  18/LO/0367

• Date of REC Opinion

  8 May 2018

• REC opinion

  Further Information Favourable Opinion