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Trial Title:
A Phase I/II, Open-label, Multi-center Study of [225Ac]Ac-PSMA-R2 in Men With PSMA-positive Prostate Cancer With or Without Prior 177Lu-PSMA Radioligand Therapy.
NCT ID:
NCT05983198
Condition:
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Conditions: Official terms:
Prostatic Neoplasms
Edetic Acid
Gallium 68 PSMA-11
Conditions: Keywords:
225Ac-PSMA-R2
dose limiting toxicity
DLT
Escalation with Overdose Control
EWOC
pre- and post-177Lu-PSMA-RLT
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
225Ac-PSMA-R2
Description:
PSMA-R2 is a ligand coupled with 225Ac an alpha emitting radionuclide
Arm group label:
Group-1 (post-177Lu)
Arm group label:
Group-2 (pre-177Lu)
Intervention type:
Radiation
Intervention name:
68Ga-PSMA-R2
Description:
Kit for radiopharmaceutical preparation
Arm group label:
Group-1 (post-177Lu)
Arm group label:
Group-2 (pre-177Lu)
Intervention type:
Radiation
Intervention name:
68Ga-PSMA-11
Description:
Kit for radiopharmaceutical preparation
Arm group label:
Group-1 (post-177Lu)
Arm group label:
Group-2 (pre-177Lu)
Other name:
Locametz
Summary:
The purpose of the study is to characterize the safety, tolerability, pharmacokinetics
(PK), and anti-tumor activity of 225Ac-PSMA-R2 in male adult participants with metastatic
castration-resistant prostate cancer (mCRPC) previously treated with androgen receptor
pathway inhibitors in post-177Lu and pre-177Lu settings.
Detailed description:
This is an open label, phase I/II, multi-center study which contains two treatment groups
(Group 1 and Group 2). Each group has a dose escalation part, once the Maximum Tolerated
Dose/Recommended Dose for Expansion (MTD/RDE) is determined in each of the dose
escalation parts, the study will continue with an expansion part in the respective group.
The dose escalation parts will establish the MTD/RDE of the 225Ac-PSMA-R2 guided by the
well-established Bayesian Logistic Regression Model (BLRM) method. The adaptive BLRM will
be guided by the Escalation with Overdose Control (EWOC) principle to control the risk of
DLT in future participants on study. Dose escalation decisions will be performed by the
Investigators and Novartis during dose escalation meetings (DEMs) based on safety and
tolerability information (BLRM summaries of DLT risk) along with PK and preliminary
efficacy information.
The dose expansion parts will assess the anti-tumor activity (Overall Response Rate (ORR)
by Prostate Cancer Working Group 3 (PCWG3) modified RECIST 1.1 and Prostate Specific
Antigen 50 (PSA50) response rate) as well as further assess the safety, tolerability, and
PK of 225Ac-PSMA-R2.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Evidence of PSMA-positive disease by 68Ga-PSMA-11 PET/CT and eligible as determined
by central reading
- Documented progressive mCRPC
- Adequate organ function (bone marrow reserve, hepatic, renal)
- 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 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Jean-Perrin
Address:
City:
Clermont-Ferrand
Zip:
63011
Country:
France
Status:
Recruiting
Contact:
Last name:
Hakim Mahammedi, Dr
Phone:
+33 47 327 8080
Facility:
Name:
Centre Georges Francois Leclerc
Address:
City:
Dijon
Zip:
21079
Country:
France
Status:
Active, not recruiting
Facility:
Name:
CLCC Centre Leon Berard
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Contact:
Last name:
Armelle Vinceneux, Dr
Phone:
+33 47 878 2646
Facility:
Name:
CHU Nantes Hopital Hotel Dieu
Address:
City:
Nantes Cedex 1
Zip:
44093
Country:
France
Status:
Recruiting
Contact:
Last name:
Francoise Kraeber Bodere, Dr.
Phone:
+33 2 40 08 33 33
Facility:
Name:
Institut de Cancerologie de l Ouest
Address:
City:
Saint Herblain
Zip:
44805
Country:
France
Status:
Active, not recruiting
Facility:
Name:
CHU de Nancy
Address:
City:
Vandoeuvre les Nancy
Zip:
54511
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre Olivier, Dr
Phone:
+33 3 83 85 85 85
Start date:
November 7, 2023
Completion date:
October 28, 2027
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05983198
