Status:
ACTIVE_NOT_RECRUITING
Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE1
PHASE2
Brief 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) w...
Detailed Description
The study contains three groups (Group 1, Group 2, and Group 3). Each group has a dose escalation part at a specific dosing schedule followed by a dose expansion part. The dose escalation parts in eac...
Eligibility Criteria
Inclusion
- Key
- 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).
- Key
Exclusion
- Any other investigational agents within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy
- Any systemic anti-cancer therapy within 28 days of the anticipated C1D1 of 225Ac-PSMA-R2 therapy
- Uncontrolled pain or incompatibility that may result in participant's lack of ability to comply with imaging procedures
- History of CNS metastases and symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
- History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months prior to ICF signature and/or clinically active significant cardiac disease
- Diagnosis of other malignancies in the past three years expected to alter life expectancy or may interfere with disease assessment
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2029
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT05983198
Start Date
November 7 2023
End Date
November 5 2029
Last Update
December 22 2025
Active Locations (12)
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1
BAMF Health
Grand Rapids, Michigan, United States, 49503
2
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
3
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
4
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004