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NCT05011188 · ClinicalTrials.gov registry record · Phase 1
FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer
A Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Rahul Aggarwal.
- Active
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT05011188: Active Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, sponsored by Rahul Aggarwal.
NCT05011188 is a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer that is active but no longer recruiting, run by Rahul Aggarwal. The registered enrollment target is 44 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05011188, a Phase 1 study of Prostate Cancer and Metastatic Castration-Resistant Prostate Cancer, is active but no longer recruiting, sponsored by Rahul Aggarwal.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on abiraterone. FOR46 is designed to target and bind to CD46, a transmembrane cellular protein expressed at moderate or high levels in numerous cancer types. The investigators hypothesize that the combination of FOR46 plus enzalutamide will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients.
Primary Outcome
A minimum of 3 patients will be treated at each dose level. If \< 33%of patients (i.e. 0 of 3 patients, or 1 of 6 patients) within a cohort have a dose-limiting toxicity (DLT in Cycle 1, then enrollment of the next cohort may commence upon approval of Data and Safety Monitoring Committee. At any dose level, dose escalation will be discontinued if \>= 2 of 3 to 6 patients within a cohort experience a DLT in Cycle 1, the MTD will have been exceeded. The previous dose level will then be considered
Conditions Studied
Interventions
- DRUG Pegfilgrastim
- BIOLOGICAL FOR46
- BIOLOGICAL Enzalutamide
- PROCEDURE Blood Samples
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-01-19 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
What the registry record for NCT05011188 still lists
NCT05011188 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pegfilgrastim is the first listed.
NCT05011188 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05011188 about?
NCT05011188 is a clinical study titled "FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer". This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on abiraterone. FOR46 is designed to target and bind to CD46, a transmembrane cellular protein expressed at moderate or high l...
What is the current status of trial NCT05011188?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2022-01-19. Estimated completion is 2027-07-31.
What conditions does trial NCT05011188 study?
This clinical trial studies the following conditions: Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer.
What interventions are being tested in trial NCT05011188?
The interventions under investigation include: Pegfilgrastim (DRUG), FOR46 (BIOLOGICAL), Enzalutamide (BIOLOGICAL), Blood Samples (PROCEDURE).
Who is sponsoring clinical trial NCT05011188?
This trial is sponsored by Rahul Aggarwal, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05011188 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05011188's enrollment target sits among peer trials
44 514th of 735 higher than 221 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.
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