NCT01148849

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started Jul 2010

Longer than P75 for phase_1 breast-cancer

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2022

Completed
Last Updated

February 26, 2025

Status Verified

February 1, 2025

Enrollment Period

12 years

First QC Date

June 17, 2010

Last Update Submit

February 24, 2025

Conditions

Breast CancerGastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Adverse Events and Serious Adverse Events

    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.

    Up to 28 days after last infusion

Secondary Outcomes (21)

  • Number of participants with dose limiting toxicities for weekly dosing

    up to Study Day 28 for weekly dosing

  • Number of participants with dose limiting toxicities every 3-week dosing

    Up to Study Day 21 day for every 3-week dosing

  • Concentration of Margetuximab at Steady State once-weekly doses of margetuximab

    Study Day 1, 2, 4, 5, 8, 15, 22, 29 ,36, 50, every 4 weeks thereafter throughout study completion, average 2 months.

  • Number of patients who develop treatment-emergent anti-drug antibodies to margetuximab (Immunogenicity)

    Study Day 1, 22, 50, every 4 weeks thereafter throughout study completion, average 2 months.

  • Maximum Concentration of Margetuximab at Steady State once every 3 weeks schedule

    Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter throughout study completion, average 10 months.

  • +16 more secondary outcomes

Study Arms (8)

Cohort 1: 0.1 mg/kg weekly for 4 weeks

EXPERIMENTAL

Anti-HER2 monoclonal antibody (margetuximab)

Biological: margetuximab

Cohort 2: 0.3 mg/kg weekly for 4 weeks

EXPERIMENTAL

Anti-HER2 monoclonal antibody (margetuximab)

Biological: margetuximab

Cohort 3: 1.0 mg/kg weekly for 4 weeks

EXPERIMENTAL

Anti-HER2 monoclonal antibody (margetuximab)

Biological: margetuximab

Cohort 4: 3.0 mg/kg weekly for 4 weeks

EXPERIMENTAL

Anti-HER2 monoclonal antibody (margetuximab)

Biological: margetuximab

Cohort 5: 6.0 mg/kg weekly for 4 weeks

EXPERIMENTAL

Anti-HER2 monoclonal antibody (margetuximab)

Biological: margetuximab

Cohort 6: 10 mg/kg weekly every 3 weeks

EXPERIMENTAL

Anti-HER2 monoclonal antibody (margetuximab)

Biological: margetuximab

Cohort 7: 15 mg/kg weekly every 3 weeks

EXPERIMENTAL

Anti-HER2 monoclonal antibody (margetuximab)

Biological: margetuximab

Cohort 8: 18 mg/kg weekly every 3 weeks

EXPERIMENTAL

Anti-HER2 monoclonal antibody (margetuximab)

Biological: margetuximab

Interventions

margetuximabBIOLOGICAL

margetuximab

Also known as: MGAH22
Cohort 1: 0.1 mg/kg weekly for 4 weeksCohort 2: 0.3 mg/kg weekly for 4 weeksCohort 3: 1.0 mg/kg weekly for 4 weeksCohort 4: 3.0 mg/kg weekly for 4 weeksCohort 5: 6.0 mg/kg weekly for 4 weeksCohort 6: 10 mg/kg weekly every 3 weeksCohort 7: 15 mg/kg weekly every 3 weeksCohort 8: 18 mg/kg weekly every 3 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed carcinoma that overexpresses HER2 by immunohistochemistry (2+ or 3+ positivity by HercepTest or equivalent).
  • Progressive disease during or after last treatment regimen.
  • Appropriate treatment history for histological entity.
  • ECOG Performance Status \<= 1.
  • Life expectancy \>= 3 month.
  • Measurable disease
  • Acceptable laboratory parameters and adequate organ reserve.
  • Baseline LVEF \>50%

You may not qualify if:

  • Lifetime anthracycline exposure \> 350 mg/m2 of doxorubicin or equivalent
  • Major surgery within four weeks before enrollment.
  • Known hypersensitivity to murine or recombinant proteins, polysorbate 80, or any excipient contained in the drug formulation.
  • Second primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score \< 6), or resected melanoma in situ are exceptions and do not require a 3 year remission.
  • Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within four weeks of enrollment. Patients requiring any oral antiviral, fungal, or bacterial therapy must have completed treatment within one week of enrollment.
  • History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.
  • History of deep vein thrombosis, pulmonary embolism, myocardial infarction, or stroke within three months of enrollment.
  • Known history of central nervous system (CNS) metastatic disease with evidence of residual or recurrent disease upon entry.
  • New York Heart Association class III or IV heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Bang YJ, Giaccone G, Im SA, Oh DY, Bauer TM, Nordstrom JL, Li H, Chichili GR, Moore PA, Hong S, Stewart SJ, Baughman JE, Lechleider RJ, Burris HA. First-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors. Ann Oncol. 2017 Apr 1;28(4):855-861. doi: 10.1093/annonc/mdx002.

    PMID: 28119295DERIVED

MeSH Terms

Conditions

Breast NeoplasmsStomach Neoplasms

Interventions

margetuximab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

July 1, 2010

Primary Completion

June 14, 2022

Study Completion

June 14, 2022

Last Updated

February 26, 2025

Record last verified: 2025-02

Locations

KR(1)US(2)