HER2 Positive Metastatic Breast CancerPhase 1NCT04398108
A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC
A Phase 1 study testing Margetuximab Margetuximab-IV in people with HER2 Positive Metastatic Breast Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 3 sites in China.
Trial summary
This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast cancer who have received standard anti-HER2 directed therapy in the metastatic setting (mandatory including trastuzumab). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 Positive Metastatic Breast Cancer
- What is being tested?
- Margetuximab Margetuximab-IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesChina
- Study dates
- 25 Aug 2020to 27 Apr 2021
- 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
- Written informed consent obtained prior to performing any protocol-related procedures
- Male or female, age ≥ 18 years old at the time of screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subject has histologically confirmed HER2 positive metastatic breast cancer.
- Have received standard anti-HER2 directed therapy in the metastatic setting (mandatory to have trastuzumab), regardless of having received (neo)adjuvant anti-HER2 therapy or not.
- Have received treatment with no more than four lines of therapy overall in the metastatic setting (including anti-HER2 targeted therapy or chemotherapy) and must have disease progressed on or after, the most recent line of therapy. per RECIST 1.1.
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- Previous adverse events associated with anti-tumor therapy have been recovered to NCI-CTCAE v4.03 Grade ≤1 (except NCI-CTCAE v4.03 Grade ≤2 alopecia, stable sensory neuropathy, or stabilized electrolyte disturbance after fluid transfusion).
- Subject has life expectancy ≥12 weeks.
- Subject has no supportive therapy of blood transfusion or growth factor within 4 weeks before dosed and has adequate organ functions
- Subject has a negative test result of pregnancy test at screening.
Who cannot join
- Subject has symptomatic, uncontrolled brain or pia mater metastasis.
- Subject has third interstitial effusion that cannot be controlled by drainage or other means.
- Subject has local or systemic anti-tumor treatment within 2 weeks prior to enrollment
- Subject has any investigational treatment within 4 weeks prior to enrollment (including margetuximab)
- Subject has history of major surgery with unrecovered surgical effect within 4 weeks prior to enrollment
- Subject has other malignant tumor (complete cured in situ cervical cancer, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma are not included) within 5 years prior to enrollment
- Subject has severe and uncontrolled disease
Trial locations and contacts
3 sites in 1 country.
China3 sites
The fifth medical center of the General Hospital of people's Liberation Army of China
Beijing, Beijing Municipality, 100071
The fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: An Open-Label, Single-arm, Phase I Study to Evaluate the Pharmacokinetics, Tolerability and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies
This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast cancer who have received standard anti-HER2 directed therapy in the metastatic setting (mandatory including trastuzumab).
The primary endpoint of this study is PK parameters of margetuximab.
Read the detailed description
Approximately 16~20 Chinese subjects will be enrolled. Eligible subjects are HER2 positive, metastatic breast cancer who has received standard anti-HER2 directed therapy in the metastatic setting in Chinese patients. Subjects should have received treatment with at least one, and no more than four lines of therapy overall in the metastatic setting.
Eligible subjects will receive margetuximab plus chemotherapy. The dosage and administering of margetuximab is 15 mg/kg IV Q3W. Investigators selected one of three backbone chemotherapy regimens given at standard doses: capecitabine, vinorelbine or gemcitabine. Subject will receive the treatment until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anti-tumor treatment therapy, or death (whichever occurs first).
- Conditions
- HER2 Positive Metastatic Breast Cancer
- Being tested
- Margetuximab Margetuximab-IV
- Keywords
- Metastatic Breast Cancer, MBC, HER2, Margetuximab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Margetuximab Margetuximab-IVDrug
Drug: Chosen Chemotherapy (Capecitabine) -Oral Capecitabine tablet Drug: Chosen Chemotherapy (Vinorelbine) Vinorelbine -IV Drug: Chosen Chemotherapy (Gemcitabine) Gemcitabine -IV
| Study group | Role | What they receive |
|---|---|---|
| Margetuximab & Chosen Chemotherapy | Experimental | The dosage and administering of margetuximab is 15 mg/kg IV every 21 days. Investigators need to choose one of the 3 chemotherapies based on patient conditions. Receives: Drug: Margetuximab Margetuximab-IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pharmacokinetic parameter of margetuximab Cmax
Measured: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
Evaluation of pharmacokinetic parameter of margetuximab Tmax
Measured: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
Evaluation of pharmacokinetic parameter of margetuximab T1/2
Measured: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
Evaluation of pharmacokinetic parameter of margetuximab AUC
Measured: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events as assessed by CTC AE 4.03
Measured: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start25 Aug 2020
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2 Positive Metastatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeifei Jiang, Principal investigator, The fifth medical center of the General Hospital of people's Liberation Army of ChinaMin Yan, Principal investigator, Henan Cancer HospitalCuizhi Geng, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398108
- Sponsor's protocol ID
- ZL-MG-BC-001
- Status last verified
- Jun 2021
- First submitted
- 8 May 2020
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-arm, Phase I Study to Evaluate the Pharmacokinetics, Tolerability and Safety of Margetuximab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies
- ClinicalTrials.gov ID
- NCT04398108
- Acronym / sponsor ID
- ZL-MG-BC-001
- Conditions
- HER2 Positive Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, MBC, HER2, Margetuximab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Zai Lab (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 21 May 2020 (actual)
- 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.
This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast cancer who have received standard anti-HER2 directed therapy in the metastatic setting (mandatory including trastuzumab).
The primary endpoint of this study is PK parameters of margetuximab.
Detailed description
Approximately 16~20 Chinese subjects will be enrolled. Eligible subjects are HER2 positive, metastatic breast cancer who has received standard anti-HER2 directed therapy in the metastatic setting in Chinese patients. Subjects should have received treatment with at least one, and no more than four lines of therapy overall in the metastatic setting.
Eligible subjects will receive margetuximab plus chemotherapy. The dosage and administering of margetuximab is 15 mg/kg IV Q3W. Investigators selected one of three backbone chemotherapy regimens given at standard doses: capecitabine, vinorelbine or gemcitabine. Subject will receive the treatment until disease progression, unacceptable toxicity, withdrawal of consent, initiation of subsequent anti-tumor treatment therapy, or death (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Margetuximab & Chosen Chemotherapy | Experimental | Drug: Margetuximab Margetuximab-IVThe dosage and administering of margetuximab is 15 mg/kg IV every 21 days. Investigators need to choose one of the 3 chemotherapies based on patient conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent obtained prior to performing any protocol-related procedures
- Male or female, age ≥ 18 years old at the time of screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Subject has histologically confirmed HER2 positive metastatic breast cancer.
- Have received standard anti-HER2 directed therapy in the metastatic setting (mandatory to have trastuzumab), regardless of having received (neo)adjuvant anti-HER2 therapy or not.
Key exclusion criteria (7 listed)
- Subject has symptomatic, uncontrolled brain or pia mater metastasis.
- Subject has third interstitial effusion that cannot be controlled by drainage or other means.
- Subject has local or systemic anti-tumor treatment within 2 weeks prior to enrollment
- Subject has any investigational treatment within 4 weeks prior to enrollment (including margetuximab)
- Subject has history of major surgery with unrecovered surgical effect within 4 weeks prior to 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 |
|---|---|---|
| Margetuximab Margetuximab-IVDrug: Chosen Chemotherapy (Capecitabine) -Oral Capecitabine tablet Drug: Chosen Chemotherapy (Vinorelbine) Vinorelbine -IV Drug: Chosen Chemotherapy (Gemcitabine) Gemcitabine -IV | Drug | Margetuximab & Chosen Chemotherapy |
Primary outcome
Evaluation of pharmacokinetic parameter of margetuximab Cmax
Time frame: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
Evaluation of pharmacokinetic parameter of margetuximab Tmax
Time frame: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
Evaluation of pharmacokinetic parameter of margetuximab T1/2
Time frame: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
Evaluation of pharmacokinetic parameter of margetuximab AUC
Time frame: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020
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 14 Jun 2021.
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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.
Zeifei Jiang principal investigator
The fifth medical center of the General Hospital of people's Liberation Army of China
Min Yan principal investigator
Henan Cancer Hospital
Cuizhi Geng principal investigator
Hebei Medical University Fourth Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Margetuximab Margetuximab-IV in people with HER2 Positive Metastatic Breast Cancer, run by Zai Lab (Shanghai) Co., Ltd. at 3 sites in China.
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 10 inclusion and 7 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 14 Jun 2021. 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 China. 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?
Evaluation of pharmacokinetic parameter of margetuximab Cmax (time frame: Approximately 18 months after the first subject is randomized; anticipated evaluation Jul 2020). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2021.