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FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer
NCT05011188 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05011188
The ClinicalTrials.gov registry entry for NCT05011188 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rahul Aggarwal, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05011188 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05011188?
The interventions under investigation include: Pegfilgrastim (DRUG), FOR46 (BIOLOGICAL), Enzalutamide (BIOLOGICAL), Blood Samples (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05011188?
This trial is sponsored by Rahul Aggarwal, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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