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Clinical Trials in Australia / NCT05983198
Active, not recruiting Phase 1

Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT

NCT05983198 · tracked via the Priya Life Science Australia tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1
Started
2023-11-07
Last updated
2026-09-11

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

225Ac-PSMA-R268Ga-PSMA-R268Ga-PSMA-11

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

Study summary

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

Sex
MALE
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Key Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

  • Phase I Dose Escalation: Incidence and severity of DLTs during the DLT observation period — Up to 6 weeks after the first 225Ac-PSMA-R2 dose administration
    To determine the Recommended Dose for Expansion (RDE) and corresponding regimen for 225Ac-PSMA-R2 monotherapy in PSMA-positive in: * Group-1 (mCRPC): Participants previously treated with 177Lu-labelled PSMA-targeted RLT (post-177Lu). * Group-2 (mCRPC): Participants not treated previously with 177Lu-labelled PSMA-targeted RLT (pre-177Lu). * Group-3 (mHSPC): Participants not treated previously with 177Lu-labelled PSMA-targeted RLT (pre-177Lu).
  • Phase I Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) by group and frequency schedule — From date of the first administration of 225Ac-PSMA-R2 till 30 days safety follow-up, assessed up to approximately 15 months
    The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
  • Phase I Dose Escalation: Tolerability — Up to 6 weeks after the first 225AC-PSMA-R2 dose administration
    Frequency of dose interruptions, reductions, discontinuations, and dose intensity by group.
  • Phase ll Dose Expansion: Overall Response Rate (ORR) — From date of the first administration of 225Ac-PSMA-R2 until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to approximately 15 months
    Overall Response Rate (ORR) is defined as the proportion of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) in soft tissue according to Prostate Cancer Working Group 3 (PCWG3) -modified RECIST v1.1 in absence of bone progression (as per PCWG3).

Trial sites (9)

FacilityCityRegionStatus
Mayo Clinic Rochester Rochester Minnesota
Novartis Investigative Site Darlinghurst New South Wales
Novartis Investigative Site Montreal Quebec
Novartis Investigative Site Dijon Cote D Or
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

More Novartis Pharmaceuticals trials in Australia

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Roll-over Study to Collect and Assess Long-term Safety of Everolimus in Patients With TSC and Refractory Seizures Who Have Completed the EXIST-3 Study [CRAD001M2304] and Who Are Benefitting From Continued Treatment Active, not recruiting
A Clinical Trial to Learn About the Effects of VHB937 in People With Early Alzheimer's Disease Recruiting
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. Recruiting

Other trials for the same condition

PSMA PET Combined With MRI for the Detection of PCa Recruiting
LTFU for All Cell and Gene Therapy Studies Starting soon
A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation Recruiting
Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men with Metastatic Castration-Resistant Prostate Cancer Active, not recruiting
Phase Ib/IIa Dose Escalation and Expansion Study of [²¹²Pb]Pb-ADVC001 in Metastatic Prostate Cancer (TheraPb - Phase I/II Study). Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05983198 on ClinicalTrials.gov ↗ ← All trials in Australia