SatisfACtion: Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With mHSPC and Heavily Pre-treated PSMA-positive mCRPC, With/Without Prior 177Lu-labelled PSMA-targeted Radioligand Therapy
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is an open label, phase I/II, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mHSPC) and with metastatic castration resistant prostate cancer (mCRPC) who have received prior anti-cancer treatment and have a positive 68Ga-PSMA-11 PET scan. The purpose of this study is to learn if the study drug, \[225Ac\]Ac-PSMA-R2, is safe and tolerable, and has anti-tumor activity in treated patients.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT and eligible as determined by central reading
• Documented progressive mCRPC or mHSPC
• Adequate organ function
• Prior orchiectomy or ongoing ADT and should have received prior 177Lu-PSMA-RLT (Group1 dose escalation \& expansion) or never received 177Lu-PSMA-RLT (Group 2 and Group 3 dose escalation \& expansion).
Locations
United States
Michigan
BAMF Health
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Other Locations
Australia
Novartis Investigative Site
RECRUITING
Darlinghurst
Novartis Investigative Site
RECRUITING
Melbourne
Canada
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
RECRUITING
Montreal
France
Novartis Investigative Site
RECRUITING
Clermont-ferrand
Novartis Investigative Site
RECRUITING
Dijon
Novartis Investigative Site
RECRUITING
Lyon
Novartis Investigative Site
RECRUITING
Nantes
Novartis Investigative Site
RECRUITING
Saint-herblain
Novartis Investigative Site
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2029-11-05
Participants
Target number of participants: 70
Treatments
Experimental: Group-1 (mCRPC/ post-177Lu)
1. Dose Escalation: All eligible participants with Metastatic Castration Resistant Prostate Cancer (mCRPC) who have received anti-cancer treatment (post-Androgen Receptor Pathway Inhibitors (ARPI), post-taxane based chemotherapy and heavily pre-treated and having already received prior 177Lu-labelled Prostate Specific Membrane Antigen (PSMA)-targeting Radioligand Therapy (RLT) will receive the starting dose of 7 Megabecquerel (MBq) of 225Ac-PSMA-R2 to determine the Maximum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE) of Group 1.~2. Dose Expansion: Once RDE is determined for Group 1, participants who have previously received 177Lu-PSMA-RLT will be enrolled in Group 1 dose expansion.
Experimental: Group-2 (mCRPC/ pre-177Lu)
1. Dose Escalation: All eligible participants with mCRPC who have received anti-cancer treatment (post-Androgen Receptor Pathway Inhibitors (ARPI), prior taxane-based chemotherapy is not required, but have never been treated with 177Lu-labelled PSMA-targeted RLT (177Lu-labelled PSMA-targeted RLT treatment naïve) will receive the starting dose of 7 Megabecquerel (MBq) of 225Ac-PSMA-R2 to determine the Maximum Tolerated Dose/Recommended Dose for Expansion (MTD/RDE) of Group 2.~2. Dose Expansion: Once RDE is determined for Group 2, participants naïve to 177Lu-labelled PSMA-targeted Radioligand Therapy (RLT) will be enrolled in Group 2 dose expansion.
Experimental: Group 3 (mHSPC/ pre-177Lu)
1. Dose Escalation: All eligible participants with mHSPC (177Lu-labelled PSMA-targeted RLT treatment naïve), who are treatment naive or minimally treated with a) luteinizing hormone-releasing hormone (LHRH) agonist/antagonists or bilateral orchiectomy with or without first generation antiandrogen (e.g. bicalutamide, flutamide) b) CYP17 inhibitor or ARDT exposure. Patient in this group will start treatment with 225Ac-PSMA-R2 after group 1 and group 2 patients.~2. Dose Expansion: Once RDE is determined for Group 3, participants will be enrolled in Group 3 dose expansion.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals