Breast CancerPhase 1NCT01148849
Safety Study of MGAH22 in HER2-positive Carcinomas
A Phase 1 study testing margetuximab in people with Breast Cancer and Gastric Cancer, run by MacroGenics at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gastric Cancer
- What is being tested?
- margetuximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2010to 14 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
National Cancer Institute
Bethesda, Maryland, 20892
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: A Phase 1, Dose Escalation Study of MGAH22 in Patients With Refractory HER2 Positive Breast Cancer and Patients With Other HER2 Positive Carcinomas for Whom No Standard Therapy Is Available
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.
- Conditions
- Breast Cancer, Gastric Cancer
- Being tested
- margetuximab
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
margetuximabBiological
Also called MGAH22
margetuximab
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 0.1 mg/kg weekly for 4 weeks | Experimental | Anti-HER2 monoclonal antibody (margetuximab) Receives: Biological: margetuximab |
| Cohort 2: 0.3 mg/kg weekly for 4 weeks | Experimental | Anti-HER2 monoclonal antibody (margetuximab) Receives: Biological: margetuximab |
| Cohort 3: 1.0 mg/kg weekly for 4 weeks | Experimental | Anti-HER2 monoclonal antibody (margetuximab) Receives: Biological: margetuximab |
| Cohort 4: 3.0 mg/kg weekly for 4 weeks | Experimental | Anti-HER2 monoclonal antibody (margetuximab) Receives: Biological: margetuximab |
| Cohort 5: 6.0 mg/kg weekly for 4 weeks | Experimental | Anti-HER2 monoclonal antibody (margetuximab) Receives: Biological: margetuximab |
| Cohort 6: 10 mg/kg weekly every 3 weeks | Experimental | Anti-HER2 monoclonal antibody (margetuximab) Receives: Biological: margetuximab |
| Cohort 7: 15 mg/kg weekly every 3 weeks | Experimental | Anti-HER2 monoclonal antibody (margetuximab) Receives: Biological: margetuximab |
| Cohort 8: 18 mg/kg weekly every 3 weeks | Experimental | Anti-HER2 monoclonal antibody (margetuximab) Receives: Biological: margetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 28 days after last infusion
Secondary outcomes (21)
Number of participants with dose limiting toxicities for weekly dosing
Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab
Measured: up to Study Day 28 for weekly dosing
Number of participants with dose limiting toxicities every 3-week dosing
Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab
Measured: Up to Study Day 21 day for every 3-week dosing
Concentration of Margetuximab at Steady State once-weekly doses of margetuximab
Measured: 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)
Measured: 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
Measured: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter throughout study completion, average 10 months.
Area Under the Concentration Time Curve at Steady State (AUC ss) once every 3 weeks schedule
AUC is a mathematical calculation that describes the drug concentration in the blood over time.
Measured: Study Day 1 through Day 22
Area Under the Concentration Time Curve at Steady State (AUC ss) weekly dosing schedule
AUC is a mathematical calculation that describes the drug concentration in the blood over time.
Measured: Study Day 1 through Day 8
Clearance once every 3 weeks schedule
Drug clearance is the amount of drug removed from the bloodstream per unit of time.
Measured: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter through study completion, average 10 months
Volume of Distribution at Steady State once every 3 weeks
The volume of distribution is related to a whether how much drug is distributed to body tissues or remains in the bloodstream
Measured: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter through study completion, average 10 months
Terminal Half-life once every 3 weeks schedule
Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
Measured: Study Day 1 through Day 22
Terminal Half-life once every weekly dosing schedule
Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
Measured: Study Day 1 through Day 8
Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab once every 3 weeks schedule
Measured: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter through study completion, average 10 months
Number of Patients with a Complete Response (CR) or Partial Response (PR) to Treatment
Investigate the preliminary anti-tumor activity as measured by response to treatment of margetuximab, using conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Measured: Assessed at 6, 18, 30, 42, and 54 weeks, they every 24 weeks until treatment discontinuation, average 10 months
Duration of response
Duration of response is calculated at the time from CR or PR to relapse or cancer progression
Measured: Assessed at 6, 18, 30, 42, and 54 weeks, they every 24 weeks until treatment discontinuation,average 10 months
Progression free survival
The interval between the first dose of study medication and progression of disease or death from any cause
Measured: Assessed at 6, 18, 30, 42, and 54 weeks, they every 24 weeks until treatment discontinuation, average 10 months
Number of patients with complete response, partial response, stable disease, or progressive disease according to each CD16A-158 genotype (FF, FV, VV)
Fc Receptor polymorphisms may affect responsiveness to immunotherapies
Measured: Fc receptor genotypes assessed prior to study treatment. Response to treatment assessed at 6, 18, 30, 42, and 54 weeks, then every 24 weeks until treatment discontinuation, average 10 months
Changes in immune cell subsets
Changes in immune cell subsets may affect responsiveness to immunotherapies
Measured: Before infusion and 1 hour after infusion on Study Day 1, Study Day 2, before infusion on Study Day 22 and 50
Serum cytokines in the blood
Changes in the levels of cytokines in the blood may be related to an immune response to treatment.
Measured: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter through study completion, average 10 months
Amount HER2 in the blood
Levels of HER2 in the bloodstream may indicate response to treatment.
Measured: Before infusion and 1 hour after infusion on Study Day 1, Study Day 2, before infusion on Study Day 22 and 50
Antibody dependent cellular cytotoxicity (ADCC) activity
ADCC activity is the ability of immune cells (like lymphocytes) to kill cells that have immune markers (like HER2) on the cell surface
Measured: Before infusion and 1 hour after infusion on Study Day 1, Study Day 2, before infusion on Study Day 22 and 50
Fc receptor occupancy
Fc receptor occupancy is the amount of time that the receptor is bound to an immune marker (like HER2) on the cell surface.
Measured: Before infusion and 1 hour after infusion on Study Day 1, Study Day 2, before infusion on Study Day 22 and 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJul 2010
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Green Cross Corporation, National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148849
- Sponsor's protocol ID
- CP-MGAH22-01
- Other IDs
- 02598-10
- Status last verified
- Feb 2025
- First submitted
- 17 Jun 2010
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28119295
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose Escalation Study of MGAH22 in Patients With Refractory HER2 Positive Breast Cancer and Patients With Other HER2 Positive Carcinomas for Whom No Standard Therapy Is Available
- ClinicalTrials.gov ID
- NCT01148849
- Acronym / sponsor ID
- CP-MGAH22-01
- Conditions
- Breast Cancer, Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Collaborators
- Green Cross Corporation, National Cancer Institute (NCI)
- Study start
- Jul 2010
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 0.1 mg/kg weekly for 4 weeks | Experimental | Biological: margetuximabAnti-HER2 monoclonal antibody (margetuximab) |
| Cohort 2: 0.3 mg/kg weekly for 4 weeks | Experimental | Biological: margetuximabAnti-HER2 monoclonal antibody (margetuximab) |
| Cohort 3: 1.0 mg/kg weekly for 4 weeks | Experimental | Biological: margetuximabAnti-HER2 monoclonal antibody (margetuximab) |
| Cohort 4: 3.0 mg/kg weekly for 4 weeks | Experimental | Biological: margetuximabAnti-HER2 monoclonal antibody (margetuximab) |
| Cohort 5: 6.0 mg/kg weekly for 4 weeks | Experimental | Biological: margetuximabAnti-HER2 monoclonal antibody (margetuximab) |
| Cohort 6: 10 mg/kg weekly every 3 weeks | Experimental | Biological: margetuximabAnti-HER2 monoclonal antibody (margetuximab) |
| Cohort 7: 15 mg/kg weekly every 3 weeks | Experimental | Biological: margetuximabAnti-HER2 monoclonal antibody (margetuximab) |
| Cohort 8: 18 mg/kg weekly every 3 weeks | Experimental | Biological: margetuximabAnti-HER2 monoclonal antibody (margetuximab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| margetuximabAlso: MGAH22margetuximab | Biological | Cohort 1: 0.1 mg/kg weekly for 4 weeks, Cohort 2: 0.3 mg/kg weekly for 4 weeks, Cohort 3: 1.0 mg/kg weekly for 4 weeks, Cohort 4: 3.0 mg/kg weekly for 4 weeks, Cohort 5: 6.0 mg/kg weekly for 4 weeks, Cohort 6: 10 mg/kg weekly every 3 weeks, Cohort 7: 15 mg/kg weekly every 3 weeks, Cohort 8: 18 mg/kg weekly every 3 weeks |
Primary outcome
Occurrence of Adverse Events and Serious Adverse Events
Time frame: Up to 28 days after last infusion
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.
21 secondary outcomes
Number of participants with dose limiting toxicities for weekly dosing
Time frame: up to Study Day 28 for weekly dosing
Number of participants with dose limiting toxicities every 3-week dosing
Time frame: Up to Study Day 21 day for every 3-week dosing
Concentration of Margetuximab at Steady State once-weekly doses of margetuximab
Time frame: 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)
Time frame: 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
Time frame: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter throughout study completion, average 10 months.
Area Under the Concentration Time Curve at Steady State (AUC ss) once every 3 weeks schedule
Time frame: Study Day 1 through Day 22
Area Under the Concentration Time Curve at Steady State (AUC ss) weekly dosing schedule
Time frame: Study Day 1 through Day 8
Clearance once every 3 weeks schedule
Time frame: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter through study completion, average 10 months
Volume of Distribution at Steady State once every 3 weeks
Time frame: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter through study completion, average 10 months
Terminal Half-life once every 3 weeks schedule
Time frame: Study Day 1 through Day 22
Terminal Half-life once every weekly dosing schedule
Time frame: Study Day 1 through Day 8
Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab once every 3 weeks schedule
Time frame: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter through study completion, average 10 months
Number of Patients with a Complete Response (CR) or Partial Response (PR) to Treatment
Time frame: Assessed at 6, 18, 30, 42, and 54 weeks, they every 24 weeks until treatment discontinuation, average 10 months
Duration of response
Time frame: Assessed at 6, 18, 30, 42, and 54 weeks, they every 24 weeks until treatment discontinuation,average 10 months
Progression free survival
Time frame: Assessed at 6, 18, 30, 42, and 54 weeks, they every 24 weeks until treatment discontinuation, average 10 months
Number of patients with complete response, partial response, stable disease, or progressive disease according to each CD16A-158 genotype (FF, FV, VV)
Time frame: Fc receptor genotypes assessed prior to study treatment. Response to treatment assessed at 6, 18, 30, 42, and 54 weeks, then every 24 weeks until treatment discontinuation, average 10 months
Changes in immune cell subsets
Time frame: Before infusion and 1 hour after infusion on Study Day 1, Study Day 2, before infusion on Study Day 22 and 50
Serum cytokines in the blood
Time frame: Study Day 1, 2, 4, 5, 22, 29 ,36, 50, every 3 weeks thereafter through study completion, average 10 months
Amount HER2 in the blood
Time frame: Before infusion and 1 hour after infusion on Study Day 1, Study Day 2, before infusion on Study Day 22 and 50
Antibody dependent cellular cytotoxicity (ADCC) activity
Time frame: Before infusion and 1 hour after infusion on Study Day 1, Study Day 2, before infusion on Study Day 22 and 50
Fc receptor occupancy
Time frame: Before infusion and 1 hour after infusion on Study Day 1, Study Day 2, before infusion on Study Day 22 and 50
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Derived from this study: PubMed 28119295Bang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing margetuximab in people with Breast Cancer and Gastric Cancer, run by MacroGenics at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Adverse Events and Serious Adverse Events (time frame: Up to 28 days after last infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01148849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.