CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
ALT-801biological
Likely dose
ALT-801 0.015 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00496860
NCT00496860Phase 1Completed
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Phase I Study of ALT-801 in Patients With Progressive Metastatic Malignancies

Altor BioScience·interventional·Posted Jul 4, 2007·Updated Jul 22, 2013

In Brief

A Phase 1 clinical trial evaluating ALT-801 for Progressive Metastatic Malignancies. Completed, enrolled 26 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProgressive Metastatic Malignancies
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2007
Enrollment StartMay 1, 2007
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 19.0 years ago

Interventions

ALT-801biological

Dose escalation (0.015 mg/kg, 0.04 mg/kg, 0.08 mg/kg, 0.12 mg/kg, 0.14 mg/kg, 0.16 mg/kg), intravenous infusions, two treatment cycle, each cycle with 4 daily on-dose infusion, 10 days rest between cycles.