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NCT06780670 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Prostate Cancer, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 443
- Enrollment target
- 20
- Study locations
NCT06780670: Recruiting Phase 2 study of Prostate Cancer, sponsored by Novartis Pharmaceuticals.
NCT06780670 is a Phase 2 study of Prostate Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 443 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06780670, a Phase 2 study of Prostate Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 443 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
Biochemical response rate as defined as the percentage of participants who achieved a ≥ 50% decrease from baseline that is confirmed by a second measurement
Conditions Studied
Interventions
- DRUG Investigators choice of SoC
- DRUG AAA817
Study Locations (20)
São Paulo
- Novartis Investigative Site - São Paulo
- Novartis Investigative Site - São Paulo
Hubei
- Novartis Investigative Site - Wuhan
- Novartis Investigative Site - Wuhan
Jiangsu
- Novartis Investigative Site - Nanjing
- Novartis Investigative Site - Nanjing
California
- VA Greater LA Healthcare System - Los Angeles
Georgia
- University Cancer and Blood Center LLC - Athens
Indiana
- Indiana University - Indianapolis
Kansas
- University of Kansas Hospital - Kansas City
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 443 participants |
| Start Date | 2025-02-27 |
| Est. Completion | 2033-07-19 |
| Phase | Phase 2 |
What NCT06780670 shows while recruiting
NCT06780670 is an interventional study that assigns participants to a tested intervention. The registered 443 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Investigators choice of SoC is the first listed.
NCT06780670 names 20 study sites across 17 states, led by São Paulo, Hubei, Jiangsu.
Frequently Asked Questions
What is clinical trial NCT06780670 about?
NCT06780670 is a clinical study titled "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". 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 t...
What is the current status of trial NCT06780670?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 443 participants. The study started on 2025-02-27. Estimated completion is 2033-07-19.
What conditions does trial NCT06780670 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT06780670?
The interventions under investigation include: Investigators choice of SoC (DRUG), AAA817 (DRUG).
Who is sponsoring clinical trial NCT06780670?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06780670 being conducted?
This trial has 20 study locations across California, Georgia, Indiana, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06780670's enrollment target sits among peer trials
443 125th of 735 higher than 611 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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