Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function

Part of paid clinical trials in New York, New York.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06004661
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • AAA617 — DRUG
    Administered intravenously once every cycles (1 cycle = 6 weeks)
  • 68Ga-PSMA-11 — DRUG
    Single intravenous dose of approximately 150 MBq

Study Details

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.

Key Dates

Start date
Apr 4, 2024
Status verified
Mar 2026
Primary completion
Jun 17, 2026
Completion
Jun 17, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: AAA617
    Participants will receive a dose of 7.4 GBq (200 mCi) ± 10% of AAA617 which will be administered once every 6 weeks (1 cycle) for up to 6 cycles if enrolled in Cohorts A or B. Participants with severe renal impairment (in cohort C) will receive a dose of 7.4 GBq of AAA617 for up to 3 cycles of treatment. 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.

Primary Outcome Measure

Absorbed radiation dose in kidneys and selected organs [ Time Frame: Up to 36 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Hosp Med SchoolNew YorkNew York10029
Ilda Bander
[email protected]
212-241-6500
Nasrin Ghesani (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Hosp Med School· New York, NY

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