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NCT04886986 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT04886986: Recruiting Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT04886986 is a Phase 1 study that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04886986, a Phase 1 study, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a phase I dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA small molecule. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells). This phase of the study (phase I) will determine the highest dose of the study intervention that can be safely given.
Primary Outcome
DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Interventions
- DRUG 68Ga-PSMA-11
- DRUG 177Lu-PSMA-617
- DRUG 225Ac-J591
- DRUG 177Lu-PSMA-I&T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-06-30 |
| Est. Completion | 2029-12 |
| Phase | Phase 1 |
What NCT04886986 shows while recruiting
NCT04886986 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 4 interventions - of which 68Ga-PSMA-11 is the first listed.
NCT04886986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04886986 about?
NCT04886986 is a clinical study titled "Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer". This is a phase I dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA small molecule. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells)...
What is the current status of trial NCT04886986?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2021-06-30. Estimated completion is 2029-12.
What interventions are being tested in trial NCT04886986?
The interventions under investigation include: 68Ga-PSMA-11 (DRUG), 177Lu-PSMA-617 (DRUG), 225Ac-J591 (DRUG), 177Lu-PSMA-I&T (DRUG).
Who is sponsoring clinical trial NCT04886986?
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 NCT04886986's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 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
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