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NCT02262910 · ClinicalTrials.gov registry record · Phase 1
Study of ES414 in Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study, sponsored by Aptevo Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
NCT02262910 is a Phase 1 study that has completed, run by Aptevo Therapeutics. The registered enrollment target is 35 participants.
The verdict
NCT02262910, a Phase 1 study, has completed, sponsored by Aptevo Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
Study Summary
The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to identify the maximum tolerated dose (MTD) of ES414 administered intravenously to patients with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, cytokine response, and clinical activity of ES414. The primary objective of Stage 2 of the study is to evaluate the clinical activity of ES414 in patients that have or have not received prior chemotherapy. Secondary objectives are to further characterize the safety profile, PK, PD, and immunogenicity of ES414.
Interventions
- BIOLOGICAL ES414
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-01 |
| Est. Completion | 2019-02-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02262910
The ClinicalTrials.gov registry entry for NCT02262910 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Aptevo Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ES414 is the first listed.
NCT02262910 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02262910 about?
NCT02262910 is a clinical study titled "Study of ES414 in Metastatic Castration-Resistant Prostate Cancer". The study will be conducted in 2 Stages. The primary objective of Stage 1 of the study is to identify the maximum tolerated dose (MTD) of ES414 administered intravenously to patients with mCRPC. Secondary objectives are to evaluate the tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immu...
What is the current status of trial NCT02262910?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2015-01. Estimated completion is 2019-02-18.
What interventions are being tested in trial NCT02262910?
The interventions under investigation include: ES414 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02262910?
This trial is sponsored by Aptevo Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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