CAAA802A12101- [225Ac]Ac-PSMA-R2 in men with heavily pre-treated PSMA positive metastatic castration

• Research type

  Research Study

• Full title

  SatisfACtion: A Phase I/II, open-label, multi-center study of [225Ac]Ac-PSMA-R2 in men with heavily pre-treated PSMA positive metastatic castration resistant prostate cancer (mCRPC) with or without prior 177Lu-labelled PSMA-targeted radioligand therapy.

• IRAS ID

  1009939

• Contact name

  Daniel Monney

• Contact email

  daniel.monney@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2021-003478-30

• Clinicaltrials.gov Identifier

  NCT05983198

• Research summary

  The purpose of this study is to find the safest dose of [225Ac] Ac-PSMA-R2. Participants will be among the first participants to receive [225Ac] Ac-PSMA-R2. The study treatment ([225Ac] Ac-PSMA-R2) has not been studied in prostate cancer. Participants will receive both [68Ga] Ga-PSMA-R2 and [68Ga] Ga-PSMA-11 as imaging agents and [225Ac] Ac-PSMA-R2 as a therapeutic agent in addition to the best supportive/best standard of care (BSC/BSOC) treatment. The imaging agents will be given through the vein in the participants arm as a single injection. The treatment being tested in this study, also called “radioligand therapy”, is an approach for the treatment of cancer that uses chemical compounds (sometimes referred to as “tumour-targeting agents”) to deliver radiation directly to kill the tumour. The compound and the radiation reach tumour cells throughout the body by travelling through the bloodstream. The compound which carries the radiation will target the tumour cells and not healthy normal tissue.
  Prostate cancer is a malignant disease which develops in the prostate gland. When cancer has spread past the prostate into the body, it is called metastatic, but it can be blocked or stopped to slow cancer growth with hormone therapy, also called androgen deprivation therapy (ADT) or androgen receptor pathway inhibitor (ARPI) therapy. Metastatic castration-resistant prostate cancer (mCRPC) is metastatic prostate cancer that has stopped responding to ADT. Many prostate cancer cells, including mCRPC, produce a protein on their surface called prostate-specific membrane antigen (PSMA). In normal cells in the prostate there is normally less PSMA protein present on the surface than in cancer cells. The compound used in this study that seeks and finds the PSMA protein is called [225Ac] Ac-PSMA-R2. It delivers actinium 225 (a radioactive metal) to prostate cells which have PSMA protein on the cell surface.

• REC name

  London - Central Research Ethics Committee

• REC reference

  24/LO/0579

• Date of REC Opinion

  18 Sep 2024

• REC opinion

  Further Information Favourable Opinion