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.
Additional locations may be listed on ClinicalTrials.gov for NCT06004661.
Locations matching your search criteria
United States
New York
New York
Icahn School of Medicine at Mount SinaiStatus: Active
Name Not Available
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
screening.
All participants will undergo a 68Ga-PSMA-11 PET/CT scan at screening to confirm PSMA
positivity.
Participants will receive a dose of 7.4 GBq (±10%) of AAA617 once every 6 weeks for a
planned 6 cycles for cohorts A and B and 3 cycles for cohort C. Based on the emerging
safety data and if the investigators deem the participant is still benefiting from study
drug, 3 additional cycles may be administered for cohort C participants.
After treatment period, participants will be asked to join a long term follow up (LTFU)
study to monitor their safety up to 10 years after the 1st dose of AAA617. In case of the
LTFU study is not available at the time of end of treatment period (safety follow-up
visit), participants will continue in Long Term Follow-up period in this study for up to
one year until they can roll over into the separate LTFU study.
The primary outcome will be to determine the effect of radiation absorption in kidney and
other organs at risk as well as the concentration in blood and derived PK parameters from
radioactivity in blood in PSMA-positive mCRPC participants with moderate and severe renal
impairment. In addition, the study will assess the relationship between drug
concentrations and QTcF.
Approximately 20 participants will be enrolled in the study with at least 6 evaluable
participants per cohort.
Lead OrganizationNovartis Pharmaceuticals Corporation