An Open-label Dosimetry, Biodistribution, Tolerability and Safety Study of Lutetium (177Lu) Vipivotide Tetraxetan in Participants With Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Moderately and Severely Impaired and With Normal Renal Function.
Novartis Pharmaceuticals
Summary
This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) administered to participants with progressive PSMA-positive metastatic castration-resistant prostate cancer. The study will also characterize the risk of QT prolongation of AAA617 in this participant population.
Description
This open-label, non-randomized, multicenter, single arm phase II study in mCRPC participants aims to better characterize the safety and tolerability of AAA617 in participants with moderate and severe renal impairment compared with normal renal function. Since both severe and moderate renal impairment have very low incidence within mCRPC participant population compared to participants with normal renal function, the enrollment will occur in parallel for the 3 cohorts; participants will be stratified in one of the three cohorts (A:normal, B: moderate or C: severe) based on their eGFR at screeni…
Eligibility
- Age range
- 18–100 years
- Sex
- Male
- Healthy volunteers
- No
Key Inclusion Criteria: 1. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 2. 68Ga-PSMA-11 Positron emission tomography (PET)/CT scan positive, and eligible as determined by the sponsor's central reader. 3. A castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). 4. Documented progressive mCRPC will be based on at least 1 of the following criteria: * Serum/plasma Prostate-Specific Antigen (PSA) progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 n…
Interventions
- DrugAAA617
Administered intravenously once every cycles (1 cycle = 6 weeks)
- Drug68Ga-PSMA-11
Single intravenous dose of approximately 150 MBq
Locations (9)
- Mount Sinai Hosp Med SchoolNew York, New York
- Novartis Investigative SiteParis
- Novartis Investigative SiteVandœuvre-lès-Nancy
- Novartis Investigative SiteEssen
- Novartis Investigative SiteMünchen
- Novartis Investigative SiteMilan