CELC-G-201

• Research type

  Research Study

• Full title

  A Phase 1/2, Open-label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination with Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

• IRAS ID

  1008905

• Contact name

  Sunni Miller

• Contact email

  smiller@celcuity.com

• Sponsor organisation

  Celcuity, Inc.

• Eudract number

  2023-505898-32

• Research summary

  The purpose of this clinical research study is to learn more about the use of the study medicine, gedatolisib, when used together with another medicine called darolutamide, for the treatment of mCRPC.
  Gedatolisib is an experimental treatment, meaning that it has not yet been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), and can only be provided as treatment in clinical studies like this one. Gedatolisib is a type of drug known as a small molecule inhibitor. This means that gedatolisib is a very small chemical structure that can enter cells easily. We hope that, when gedatolisib enters tumor cells, it can prevent or slow the growth of the tumors. Other medicines are available to treat mCRPC.
  In this study, gedatolisib will be given together with another medicine, called darolutamide (which you may also know by its brand name, NUBEQA). Darolutamide is a hormonal therapy drug that is approved in the United Kingdom for the treatment of other types of prostate cancer. It is approved to treat non-metastatic castration-resistant prostate cancer when used alone and metastatic hormone sensitive prostate cancer when used together with hormone therapy or androgen deprivation therapy (ADT). Hormone therapy or ADT uses medicines to reduce testosterone levels and treat prostate cancer. Darolutamide is also approved to treat metastatic hormone sensitive prostate cancer in combination with a drug called docetaxel. However, because darolutamide is not approved to treat mCRPC, this means that darolutamide is also an experimental treatment in this study.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  23/EM/0259

• Date of REC Opinion

  30 Nov 2023

• REC opinion

  Further Information Favourable Opinion