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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

NCT06780670 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 443

Last updated 2026-05-22

No results posted yet for this 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

Conditions

Interventions

DRUG

Investigators choice of SoC

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

DRUG

AAA817

The investigational treatment is AAA817

DRUG

AAA817

The investigational treatment is AAA817

DRUG

AAA817

Investigational treatment is the Dose B of AAA817

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-27
Primary Completion
2028-06-27
Completion
2033-07-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • China
  • Hong Kong
  • Israel
  • Japan
  • Malaysia
  • Singapore
  • South Korea
  • Switzerland
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780670 on ClinicalTrials.gov