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NCT00496860 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies
A Phase 1 study, sponsored by Altor BioScience.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT00496860: Completed Phase 1 study, sponsored by Altor BioScience.
NCT00496860 is a Phase 1 study that has completed, run by Altor BioScience. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00496860, a Phase 1 study, has completed, sponsored by Altor BioScience.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a Phase 1, open-labeled, non-randomized, multi-center, competitive enrollment and dose-escalation study of ALT-801, the study drug. The purpose of this study is to evaluate the safety, determine the maximum-tolerated dose (MTD) and characterize the pharmacokinetic profile of ALT-801 in previously treated patients with progressive metastatic malignancies. ALT-801, a recombinant fusion protein with a interleukin-2 (IL-2) component, has a targeting mechanism that recognizes tumor cells with a specific tumor marker.
Primary Outcome
Number of serious adverse events per cohort
Interventions
- BIOLOGICAL ALT-801
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-10 |
| Phase | Phase 1 |
What the finished NCT00496860 record still lists
NCT00496860 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which ALT-801 is the first listed.
NCT00496860 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00496860 about?
NCT00496860 is a clinical study titled "Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies". This is a Phase 1, open-labeled, non-randomized, multi-center, competitive enrollment and dose-escalation study of ALT-801, the study drug. The purpose of this study is to evaluate the safety, determine the maximum-tolerated dose (MTD) and characterize the pharmacokinetic profile of ALT-801 in previ...
What is the current status of trial NCT00496860?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2007-05. Estimated completion is 2009-10.
What interventions are being tested in trial NCT00496860?
The interventions under investigation include: ALT-801 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00496860?
This trial is sponsored by Altor BioScience, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00496860's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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