Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03545165 · ClinicalTrials.gov registry record · Phase 1
177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT03545165: Clinical Trial Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT03545165 is a Phase 1 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03545165, a Phase 1 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
Phase I dose escalation study with combination of 177Lu-J591 and 177Lu-PSMA-617 using a dose-fractionated regimen will be performed in patients with documented progressive metastatic CRPC. The cumulative 177Lu-J591 dose for each subject will be 2.7 GBq/m2 (73 mCi/m2) of 177Lu with 20 mg J591 and the cumulative 177Lu-PSMA-617 dose for each subject will vary (depending on the Cohort) from 3.7 GBq (100 mCi) to 18.5 GBq (500 mCi). The 177Lu-PSMA-617 dose will be escalated in up to 6 different dose levels (3+3 dose-escalation study / de-escalation design). For the phase II portion, a minimum number of 14 patients will be enrolled at MTD (including those enrolled at MTD in Phase I) and a maximum of 24.
Primary Outcome
Dose limiting toxicity of combination therapy was determined by monitoring for adverse events following therapy
Interventions
- DRUG 177Lu-PSMA-617
- DRUG 177Lu-J591
- DRUG 68Ga-PSMA-HBED-CC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-04-18 |
| Est. Completion | 2020-07-15 |
| Phase | Phase 1 |
Why NCT03545165 stopped before completion
NCT03545165 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which 177Lu-PSMA-617 is the first listed.
NCT03545165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03545165 about?
NCT03545165 is a clinical study titled "177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC". Phase I dose escalation study with combination of 177Lu-J591 and 177Lu-PSMA-617 using a dose-fractionated regimen will be performed in patients with documented progressive metastatic CRPC. The cumulative 177Lu-J591 dose for each subject will be 2.7 GBq/m2 (73 mCi/m2) of 177Lu with 20 mg J591 and the...
What is the current status of trial NCT03545165?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2018-04-18. Estimated completion is 2020-07-15.
What interventions are being tested in trial NCT03545165?
The interventions under investigation include: 177Lu-PSMA-617 (DRUG), 177Lu-J591 (DRUG), 68Ga-PSMA-HBED-CC (DRUG).
Who is sponsoring clinical trial NCT03545165?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03545165's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI