Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT
NCT ID: NCT05983198
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
29 participants
INTERVENTIONAL
2023-11-07
2029-11-05
Brief Summary
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Enrollment of all participants was not completed. The evaluated radioligand showed acceptable safety but limited benefit in metastatic prostate cancer
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
225Ac-PSMA-R2
PSMA-R2 is a ligand coupled with 225Ac an alpha emitting radionuclide
68Ga-PSMA-R2
Kit for radiopharmaceutical preparation
68Ga-PSMA-11
Kit for radiopharmaceutical preparation
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.
225Ac-PSMA-R2
PSMA-R2 is a ligand coupled with 225Ac an alpha emitting radionuclide
68Ga-PSMA-R2
Kit for radiopharmaceutical preparation
68Ga-PSMA-11
Kit for radiopharmaceutical preparation
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.
225Ac-PSMA-R2
PSMA-R2 is a ligand coupled with 225Ac an alpha emitting radionuclide
68Ga-PSMA-R2
Kit for radiopharmaceutical preparation
68Ga-PSMA-11
Kit for radiopharmaceutical preparation
Interventions
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225Ac-PSMA-R2
PSMA-R2 is a ligand coupled with 225Ac an alpha emitting radionuclide
68Ga-PSMA-R2
Kit for radiopharmaceutical preparation
68Ga-PSMA-11
Kit for radiopharmaceutical preparation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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
18 Years
100 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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BAMF Health
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Novartis Investigative Site
Darlinghurst, New South Wales, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Dijon, Cote D Or, France
Novartis Investigative Site
Clermont-Ferrand, , France
Novartis Investigative Site
Lyon, , France
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Saint-Herblain, , France
Novartis Investigative Site
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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2021-003478-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAAA802A12101
Identifier Type: -
Identifier Source: org_study_id