drugset / Trial / NCT01585688

Phase I/II Study of hLL1-DOX in Relapsed NHL and CLL

NCT01585688 ↗

Phase 1/2 Terminated 13 enrolled Gilead Sciences
NaSingle-groupOpen-labelTreatment

Summary

The primary objectives are to evaluate the safety and tolerability of hLL1-DOX, and to determine the maximum tolerated dose (MTD) regimen (in terms of a dose and its associated dosing schedule). The secondary objectives are to obtain information on efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity, and to determine the optimal dose for subsequent studies.

Timeline

Start
2012-08
Primary completion
2016-11
Completion
2017-10

Outcome

Outcome not reported

Stopped: “Study was terminated due to lack of efficacy, as a result, the stability program for the drug product was discontinued”

Drugs

EvaluationDrugModalityDoseRoute
Subject hLL1-DOX Unknown — Intravenous