Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

Investigators choice of SoC: The control treatment in Phase III is investigator's choice of SoC

AAA817: The investigational treatment is AAA817

AAA817: The investigational treatment is AAA817

AAA817: Investigational treatment is the Dose B of AAA817

Study summary

This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy.

Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is investigator's choice of Standard of Care, regardless of subsequent anti-neoplastic treatment

Eligibility

Primary outcome measure(s)

• Biochemical response rate (Phase II) — from date of randomization up to approximately 24 months
  Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement
• Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II — from day of randomization to 30 days after End of Treatment or (last AAA817 dose date + 55 days, last dose date of SoC + 30 days), whichever is later
  Safety defined as the type, incidence and severity of AEs and SAEs, and deaths
• Tolerability of the proposed dose of AAA817- Phase II — From on-treatment period which start from the first dose of study treatment until 30 days post-last dose date for SoC and 55 days post last-dose for AAA817
  Percentage of participants who experienced Dose interruptions, reductions, discontinuation, dose intensity and duration of exposure
• Radiographic progression-free survival (rPFS)- Phase III — from date of randomization up to approximately 24 months
  Percentage of participants who are alive without radiographic progression or who are lost to follow-up at the time of analysis
• Overall survival (OS)- Phase III — from date of randomization up to approximately 24 months
  Percentage of participants who are alive or who are lost to follow-up at the time of analysis

Trial sites (93)

+ 53 more sites — see the full list on the official registry below.

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