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NCT01148849 · ClinicalTrials.gov registry record · Phase 1

Safety Study of MGAH22 in HER2-positive Carcinomas

A Phase 1 study, sponsored by MacroGenics.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT01148849: Completed Phase 1 study, sponsored by MacroGenics.

NCT01148849 is a Phase 1 study that has completed, run by MacroGenics. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01148849, a Phase 1 study, has completed, sponsored by MacroGenics.

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study Summary

The purpose of this study is to determine if MGAH22 is safe when given by intravenous (IV) infusion to patients with HER2-positive cancer. The study will also evaluate how long MGAH22 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given, and whether it has an effect on tumors.

Primary Outcome

Note that serious adverse events that are considered study drug related can be reported at any time after Study Day 50 or 28 days after the last infusion.

Interventions

  • BIOLOGICAL margetuximab

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2010-07
Est. Completion 2022-06-14
Phase Phase 1
MacroGenics

36 total trials

What the finished NCT01148849 record still lists

NCT01148849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).

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

NCT01148849 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01148849 about?

NCT01148849 is a clinical study titled "Safety Study of MGAH22 in HER2-positive Carcinomas". The purpose of this study is to determine if MGAH22 is safe when given by intravenous (IV) infusion to patients with HER2-positive cancer. The study will also evaluate how long MGAH22 stays in the blood and how long it takes for it to leave the body, what is the highest dose that can safely be given...

What is the current status of trial NCT01148849?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2010-07. Estimated completion is 2022-06-14.

What interventions are being tested in trial NCT01148849?

The interventions under investigation include: margetuximab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01148849?

This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01148849's enrollment target sits among peer trials

66 786th of 2000 higher than 1,203 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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Source: ClinicalTrials.gov NCT01148849, the US trial registry maintained by the National Library of Medicine. NCT01148849 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.