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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: Completed Phase 1 study, sponsored by Aptevo Therapeutics.
NCT02262910 is a Phase 1 study that has completed, run by Aptevo Therapeutics. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Identify the maximum tolerated dose in dose-escalation stage (Stage 1) by assessment of dose-limiting toxicities
Interventions
- BIOLOGICAL ES414
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-01 |
| Est. Completion | 2019-02-18 |
| Phase | Phase 1 |
What the finished NCT02262910 record still lists
NCT02262910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which ES414 is the first listed.
NCT02262910 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02262910's enrollment target sits among peer trials
35 1258th of 2000 higher than 728 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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