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NCT01161511 · ClinicalTrials.gov registry record · Phase 1

Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia

A Phase 1 study, sponsored by Xencor.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT01161511 is a Phase 1 study that has completed, run by Xencor. The registered enrollment target is 27 participants.

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The verdict

NCT01161511, a Phase 1 study, has completed, sponsored by Xencor.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and to evaluate preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL.

Interventions

  • BIOLOGICAL XmAb5574

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2010-09
Est. Completion 2013-01
Phase Phase 1

Sponsor

Xencor

27 total trials

What the Registry Record Tells You About NCT01161511

The ClinicalTrials.gov registry entry for NCT01161511 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xencor, which has 27 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which XmAb5574 is the first listed.

NCT01161511 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01161511 about?

NCT01161511 is a clinical study titled "Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia". This is an open-label, multi-dose, single-arm, Phase 1, dose-escalation study of XmAb5574. The study was conducted to identify the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study, to characterize safety and tolerability, to characterize PK, PD and immunogenicity, and t...

What is the current status of trial NCT01161511?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-09. Estimated completion is 2013-01.

What interventions are being tested in trial NCT01161511?

The interventions under investigation include: XmAb5574 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01161511?

This trial is sponsored by Xencor, which has 27 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.