A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
PSMA-positive Metastatic Castration Resistant Prostate Cancer (mCRPC) With Prior Exposure to One Prior ARPI Who Are Candidates for Taxane-based Chemotherapy
No strong warning signs right now. The score counts warning signs; it is not a prediction.
Why this score
No warning signs right now. That's why the score is 0.
Score over time
- Stage
- Phase 1/2
- Patients
- 123 (planned)
- Started
- Dec 5, 2025
- Main results expected
- Jul 10, 2028
- Fully finished
- Sep 13, 2029
- Results posted
- not yet
What counts as success
The trial's main goal(s), called the “primary outcome.”
Phase Ib: Incidence rate of Dose-limiting toxicities (DLTs)
Measured over: Up to 42 days after the first AAA617 dose administration
Phase Ib: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over: From date of start of study treatment, assessed up to approximately 45 months
Phase Ib: Number of Participants with dose adjustments
Measured over: From date of start of study treatment, assessed up to approximately 24 months
Phase Ib: Dose Intensity
Measured over: From date of start of study treatment, assessed up to approximately 24 months
Phase Ib: Duration of exposure to each study drug
Measured over: From date of start of study treatment, assessed up to approximately 24 months
Phase II: Biochemical Response (PSA50)
Measured over: From date of start of study treatment, assessed up to approximately 24 months
Changes Tremor has spotted
Show details (technical version)
Score inputs
- none
Raw record changes
- none yet
Trial ID NCT07226986 · record last updated 2026-10-15 · checked 2026-11-09 15:47 UTC