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NCT05682443 · ClinicalTrials.gov registry record · Phase 1
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
A Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by OncoC4.
- Active
- Registry status
- Phase 1
- Development phase
- 148
- Enrollment target
- 20
- Study locations
NCT05682443: Active Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, sponsored by OncoC4.
NCT05682443 is a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer that is active but no longer recruiting, run by OncoC4. The registered enrollment target is 148 participants, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05682443, a Phase 1 study of Metastatic Castration-Resistant Prostate Cancer, is active but no longer recruiting, sponsored by OncoC4.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 148 participants
- Enrollment target
- 20
- Study locations
Study Summary
In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.
Primary Outcome
Incidence of dose-limiting toxicity (DLT).
Conditions Studied
Interventions
- DRUG ONC-392 low
- DRUG ONC-392 high
- DRUG lutetium Lu 177 vipivotide tetraxetan
Study Locations (20)
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- NYU Langone Health, Laura & Isaac Perlmutter Cancer Center - New York
- Columbia University Irving Cancer Center - New York
Maryland
- The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
- Chesapeake Urology Research Associates - Towson
North Carolina
- UNC North Carolina Comprehensive Cancer Care Center - Chapel Hill
- Duke Cancer Center - Durham
California
- UC Davis Comprehensive Cancer Center - Sacramento
Colorado
- Rocky Mountain Cancer Centers USOR - Aurora
Florida
- Moffitt Cancer Cancer - Tampa
Georgia
- Emory University Winship Cancer Institute - Atlanta
Massachusetts
- Lahey Hospital & Medical Center - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2023-12-11 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
What the registry record for NCT05682443 still lists
NCT05682443 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 196-participant average among 69 other Metastatic Castration-Resistant Prostate Cancer trials with a reported enrollment target (24% lower).
The record links to 1 condition, with Metastatic Castration-Resistant Prostate Cancer appearing as the primary indexed condition, and to 3 interventions - of which ONC-392 low is the first listed.
NCT05682443 names 20 study sites across 16 states, led by New York, Maryland, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05682443 about?
NCT05682443 is a clinical study titled "ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC". In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.
What is the current status of trial NCT05682443?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 148 participants. The study started on 2023-12-11. Estimated completion is 2027-06-30.
What conditions does trial NCT05682443 study?
This clinical trial studies the following conditions: Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT05682443?
The interventions under investigation include: ONC-392 low (DRUG), ONC-392 high (DRUG), lutetium Lu 177 vipivotide tetraxetan (DRUG).
Who is sponsoring clinical trial NCT05682443?
This trial is sponsored by OncoC4, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05682443 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Castration-Resistant Prostate Cancer
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Where NCT05682443's enrollment target sits among peer trials
148 21st of 69 higher than 49 of 69 other Metastatic Castration-Resistant Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Castration-Resistant 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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