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NCT07047118 · ClinicalTrials.gov registry record · Phase 2
A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
A Phase 2 study of Prostatic Cancer, Castration-Resistant, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT07047118: Recruiting Phase 2 study of Prostatic Cancer, Castration-Resistant, sponsored by Novartis Pharmaceuticals.
NCT07047118 is a Phase 2 study of Prostatic Cancer, Castration-Resistant that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 130 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07047118, a Phase 2 study of Prostatic Cancer, Castration-Resistant, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with metastatic Castration Resistant Prostate Cancer (mCRPC) with prior exposure to at least 1 Androgen Receptor Pathway Inhibitor (ARPI) and 0-2 taxane regimens and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and pharmacokinetic (PK) data from participants randomized in the study will be evaluated.
Primary Outcome
Prostate Specific Antigen 50 (PSA50) Rate is defined as the proportion of participants who achieve a ≥50% decrease from baseline at any timepoint, confirmed by a second PSA measurement ≥3 weeks without any PSA progression in between
Conditions Studied
Interventions
- DRUG AAA617
- DRUG JSB462
Study Locations (20)
California
- City of Hope National Medical - Duarte
- Providence Saint Johns Health Ctr - Santa Monica
Texas
- Texas Oncology Sammons Cancer Center - Dallas
- Urology San Antonio - San Antonio
Other
- Novartis Investigative Site - Linz
- Novartis Investigative Site - Vienna
Arizona
- Cancer And Blood Spclsts of AZ - Casa Grande
Arkansas
- Highlands Oncology Group - Fayetteville
Colorado
- Rocky Mountain Cancer Centers - Denver
Connecticut
- Yale University School Of Medicine - New Haven
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2025-07-03 |
| Est. Completion | 2028-11-04 |
| Phase | Phase 2 |
What NCT07047118 shows while recruiting
NCT07047118 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 1 condition, with Prostatic Cancer, Castration-Resistant appearing as the primary indexed condition, and to 2 interventions - of which AAA617 is the first listed.
NCT07047118 names 20 study sites across 17 states, led by California, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT07047118 about?
NCT07047118 is a clinical study titled "A Study of JSB462 (Luxdegalutamide) Plus Lutetium (177Lu) Vipivotide Tetraxetan in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)". This Phase II study aims to evaluate the efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg QD doses + lutetium (177Lu) vipivotide tetraxetan (hereafter referred as AAA617) compared with AAA617 (control) in participants with metastatic Castration Re...
What is the current status of trial NCT07047118?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2025-07-03. Estimated completion is 2028-11-04.
What conditions does trial NCT07047118 study?
This clinical trial studies the following conditions: Prostatic Cancer, Castration-Resistant.
What interventions are being tested in trial NCT07047118?
The interventions under investigation include: AAA617 (DRUG), JSB462 (DRUG).
Who is sponsoring clinical trial NCT07047118?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07047118 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07047118's enrollment target sits among peer trials
130 543rd of 2000 higher than 1,448 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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