HER2-positive Breast CancerPhase 1B003-101NCT03953833
B003 in Patients With HER2-positive Recurrent or Metastatic Breast Cancer
A Phase 1 study testing Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003. in people with HER2-positive Breast Cancer, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.
Trial summary
To assess the safety and tolerability characteristics of B003 in HER2-positive patients with recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) is assessed and the maximum tolerated dose (MTD) is explored. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 13 Jan 2023
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old ≤ age ≤ 75 years old, female;
- Histological or cytologically confirmed recurrent or metastatic breast cancer,Anti-HER2 treatment failure for recurrent or metastatic disease;
- According to RECIST v 1.1, patients with measurable and/or unmeasurable lesions: 1) Patients with bone metastases, as long as the bone metastases have never received radiotherapy, and the primary tumours are available for HER2 detection and Biomarker analysis, which can be enrolled.
- Female patients of childbearing age, patients and/or their partners should agree to use a highly effective non-hormonal contraceptive method or two effective non-hormonal contraceptive methods. Continue to use the appropriate contraceptive measures during the study period and at least 6 months after the last dose.
- Electrocorticography (ECOG) physical state (PS) is 0-1 points;
- Expected to survive for more than 3 months;
- Understand and voluntarily sign the informed consent form.
Who cannot join
- Previously received T-DM1 or same type of drug for treatment, previously used trastuzumab within 3 months before the trial, previously involved in other clinical trials within 4 weeks before the trial.
- Known to be allergic to the study drug or its components;
- Have received any anti-cancer trial medication within 28 days prior to the start of the trial;
- Have received hormone treatment within 7 days before the trial.
- Hematological toxicity caused by previous treatment CTCAE ≥ 2 persistence (except hemoglobin) (NCI-CTCAE version 4.03);
- A third gap effusion with clinical symptoms that cannot be controlled by drainage or other methods.
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- The cumulative dose of anthracyclines used meets the following values: doxorubicin or liposomal doxorubicin >450 mg/m2; epirubicin >900 mg/m2; mitoxantrone >120 mg/m2; Idarubicin > 90 mg/m2. If another anthracycline or more than one anthracycline is used, the cumulative dose should not exceed the equivalent dose of doxorubicin 500mg/m2
- Patients with other malignant tumors (cervical cancer of StageI B or lower that has been cured, non-invasive basal cells or squamous cell skin cancer, complete remission (CR) > 10 years of malignant melanoma, Except for other malignant tumors with complete remission (CR) > 5 years);
- Laboratory abnormalities: 1) Neutrophil count <1.5×109/L, 2) Platelet count <100×109/L, 3) Hemoglobin <90 g/L, 4) Total bilirubin > 1.5 x upper limit of normal (ULN), 5) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) > 2.5 × ULN, 6) Serum creatinine >1.5×ULN or creatinine clearance <50 mL/min;
- Currently suffering from a serious and uncontrollable systemic disease (eg, clinically significant cardiovascular disease, lung disease, active infection, or metabolic disease);
- Have a tendency to hemorrhage and thrombosis: 1) Any CTCAE 4.03 Level 2 bleeding event occurred within 2 months prior to screening, or CTCAE 4.03 Level 3 and above bleeding events within the first 6 months of screening; 2) A history of gastrointestinal bleeding within 6 months prior to screening or a clear tendency to gastrointestinal bleeding. Such as: esophageal varices with bleeding risk, local active ulcer lesions, fecal occult blood + +; 3) There is currently active bleeding or coagulopathy (PT>16s, activated partial thromboplastin time >43s, thrombin time)>21s, INR≥2.3, all of which need to be ruled out), have bleeding tendency or are receiving thrombolysis or anti- Coagulation therapy; 4) Patients need anticoagulant therapy with warfarin or heparin; 5) Patients need long-term antiplatelet therapy (eg aspirin, clopidogrel); 6) Thrombotic or embolic events in the past 6 months, such as: cerebrovascular accidents (including transient ischemic attacks), pulmonary embolism;
- History of severe cardiovascular disease: 1) According to NYHA (New York Heart Association), current cardiac function classification: grade III or IV; 2) There is currently congestive heart failure and New York Heart Association cardiac function grade II and above; 3) A history of unstable angina or myocardial infarction within 6 months prior to screening; 4) There are currently arrhythmias requiring therapeutic intervention (patients taking beta-blockers or digoxin can be enrolled); 5) According to the current two-dimensional echocardiographic results, the left ventricular ejection fraction (LVEF) is <50%; 6) Have a history of LVEF falling below 40%, or have had symptomatic congestive heart failure when treated with anti-HER2; 7) There is currently poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg); 8) Cardiac troponin I ≥ 0.2 ng/mL;
- There is a history of moderate or severe dyspnea at rest due to advanced malignancies or their complications or severe pulmonary primary disease, or current continuous oxygen therapy is required;
- Symptomatic brain metastases, depression or schizophrenia;
- History of immunodeficiency, including: HIV-positive, or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;
- Hepatitis B (HBsAg and / or HBcAb positive, and peripheral blood hepatitis B virus DNA titer test results beyond the normal range of the research center), and / or hepatitis C patients;
- Alcohol dependence, hormone dependence or drug abusers;
- The investigator believes that there are other factors that are not suitable for the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial on the Safety, Tolerability, Pharmacokinetics of B003 in the Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
To assess the safety and tolerability characteristics of B003 in HER2-positive patients with recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) is assessed and the maximum tolerated dose (MTD) is explored.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.
- Keywords
- DLT, MTD, Safety, tolerability, HER2-positive, Recombinant Humanized Anti-HER2 Monoclonal Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.Biological
Usage: Intravenous infusion; Dose escalation stage: doses 0.6, 1.2, 2.4, 3.6, 4.8 mg / kg, 1-6subjects each. Dose expansion stage: 20 subjects are enrolled and take the recommended dose based on the result of dose escalation stage.
Infusion time：90 minutes(90min-106min suggested) for the first time; if no infusion reaction happens, the follow-up time is adjusted to at least30 minutes(30min-40min suggested).Dose escalation stage: treatment cycle is administered every 21days,the infusion is taken at the first day of each treatment cycle.Observation period of DLT is the 21st day of the first treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| recombinant anti-HER2 humanized monoclonal antibody conjugate | Experimental | Drug Name : Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection R \& D code: B003 Drug Type : Biological Products Receives: Biological: Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
The maximum tolerated dose (MTD) is operationally defined in toxicology as the highest daily dose of a chemical that does not cause overt toxicity in subjects
Measured: through study completion, an average of 2 years
Dose-Limiting Toxicity
Some of the major toxic side effects are the main reasons limiting the continued increase in the dose of chemotherapy drugs, which are the dose-limiting toxicity of chemotherapy drugs.
Measured: From day 1 to day 21 of treatment
Immunogenicity assessment
Sample positive rate and Individual positive rate of Anti-drug antibody(ADA)
Measured: through study completion, an average of 2 years
Titer of ADA positive sample
a test to determine the level or degree of ADA positive samples and analyse the effect on the plasma concentration.
Measured: through study completion, an average of 2 years
Pharmacokinetics measurement A
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded.
Peak Plasma Time (Tmax)
Measured: through study completion, an average of 2 year
Pharmacokinetics measurement B
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded.
Peak Plasma Concentration (Cmax)
Measured: through study completion, an average of 2 year
Pharmacokinetics measurement C
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded.
half-life time
Measured: through study completion, an average of 2 year
Pharmacokinetics measurement D
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded.
Mean Residence Time( MRT)
Measured: through study completion, an average of 2 year
Pharmacokinetics measurement E
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded.
Area under the plasma concentration versus time curve (AUC)
Measured: through study completion, an average of 2 year
Pharmacokinetics measurement F
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded.
elimination rate constant
Measured: through study completion, an average of 2 year
Pharmacokinetics measurement G
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded.
clearance rate(CL/F)
Measured: through study completion, an average of 2 year
Therapeutic Efficacy A
Objective Remission Rate (ORR): to be defined as the percentage of patients with complete response or partial response. Patients with CR or PR for the first evaluation will be confirmed after 4weeks. Patients without any evaluations are regarded as none-response.
Measured: from date of start from the infusion of the first subject until the date after two treatments of the last subject, assessed up to 14 months.
Therapeutic Efficacy B
Disease Control rate(DCR): to be defined as the percentage of patients with complete response, partial response or stable disease.
Measured: from date of start from the infusion of the first subject until the date after two treatments of the last subject, assessed up to 14 months.
Therapeutic Efficacy C
Duration of response(DOR): to be defined as the duration from the first evaluation time when the patient has CR or PR to the first evaluation time when the patient has disease progression or death.
Measured: from the date when he patient has CR or PR to the first evaluation until the date when the patient has disease progression or death, assessed up to 14 months.
Therapeutic Efficacy D
Progression-free survival:to be defined as the duration from the time of first infusion to the first recording time when the patient has disease progression or death.
Measured: from the date when he patient has CR or PR to the first evaluation until the date when the patient has disease progression or death, assessed up to 14 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Apr 2019
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pharmaceuticals Holding Co., LtdThe sponsor's other registered studies.
- 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
- Model description
- The study is divided into the dose escalation group and the dose expansion group. Dose escalation stage: treatment cycle is administered every 21days,the infusion is taken at the first day of each treatment cycle.Observation period of DLT is from day 1 to day 21 of the first treatment cycle. Dose expansion stage: treatment cycle is administered every 21days and could be administered continuously until the disease progresses or is intolerable.DLT is not accessed during this stage. Blind method: open Test range: Domestic test
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Jiang, Principal investigator, West China HospitalYongsheng Wang, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953833
- Sponsor's protocol ID
- B003-101
- Acronym
- B003-101
- Status last verified
- Oct 2022
- First submitted
- 25 Apr 2019
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial on the Safety, Tolerability, Pharmacokinetics of B003 in the Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03953833
- Acronym / sponsor ID
- B003-101 / B003-101
- Conditions
- HER2-positive Breast Cancer
- Keywords
- DLT, MTD, Safety, tolerability, HER2-positive, Recombinant Humanized Anti-HER2 Monoclonal Antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Pharmaceuticals Holding Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 17 May 2019 (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.
To assess the safety and tolerability characteristics of B003 in HER2-positive patients with recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) is assessed and the maximum tolerated dose (MTD) is explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is divided into the dose escalation group and the dose expansion group. Dose escalation stage: treatment cycle is administered every 21days,the infusion is taken at the first day of each treatment cycle.Observation period of DLT is from day 1 to day 21 of the first treatment cycle. Dose expansion stage: treatment cycle is administered every 21days and could be administered continuously until the disease progresses or is intolerable.DLT is not accessed during this stage. Blind method: open Test range: Domestic test
| Arm | Type | Receives |
|---|---|---|
| recombinant anti-HER2 humanized monoclonal antibody conjugate | Experimental | Biological: Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.Drug Name : Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection R \& D code: B003 Drug Type : Biological Products |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old ≤ age ≤ 75 years old, female;
- Histological or cytologically confirmed recurrent or metastatic breast cancer,Anti-HER2 treatment failure for recurrent or metastatic disease;
- According to RECIST v 1.1, patients with measurable and/or unmeasurable lesions: 1) Patients with bone metastases, as long as the bone metastases have never received radiotherapy, and the primary tumours are available for HER2 detection and Biomarker analysis, which can be enrolled.
- Female patients of childbearing age, patients and/or their partners should agree to use a highly effective non-hormonal contraceptive method or two effective non-hormonal contraceptive methods. Continue to use the appropriate contraceptive measures during the study period and at least 6 months after the last dose.
Key exclusion criteria (18 listed)
- Previously received T-DM1 or same type of drug for treatment, previously used trastuzumab within 3 months before the trial, previously involved in other clinical trials within 4 weeks before the trial.
- Known to be allergic to the study drug or its components;
- Have received any anti-cancer trial medication within 28 days prior to the start of the trial;
- Have received hormone treatment within 7 days before the trial.
- Hematological toxicity caused by previous treatment CTCAE ≥ 2 persistence (except hemoglobin) (NCI-CTCAE version 4.03);
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 |
|---|---|---|
| Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.Usage: Intravenous infusion; Dose escalation stage: doses 0.6, 1.2, 2.4, 3.6, 4.8 mg / kg, 1-6subjects each. Dose expansion stage: 20 subjects are enrolled and take the recommended dose based on the result of dose escalation stage. Infusion time：90 minutes(90min-106min suggested) for the first time; if no infusion reaction happens, the follow-up time is adjusted to at least30 minutes(30min-40min suggested).Dose escalation stage: treatment cycle is administered every 21days,the infusion is taken at the first day of each treatment cycle.Observation period of DLT is the 21st day of the first treatment cycle. | Biological | recombinant anti-HER2 humanized monoclonal antibody conjugate |
Primary outcome
Maximum Tolerated Dose
Time frame: through study completion, an average of 2 years
The maximum tolerated dose (MTD) is operationally defined in toxicology as the highest daily dose of a chemical that does not cause overt toxicity in subjects
Dose-Limiting Toxicity
Time frame: From day 1 to day 21 of treatment
Some of the major toxic side effects are the main reasons limiting the continued increase in the dose of chemotherapy drugs, which are the dose-limiting toxicity of chemotherapy drugs.
Immunogenicity assessment
Time frame: through study completion, an average of 2 years
Sample positive rate and Individual positive rate of Anti-drug antibody(ADA)
Titer of ADA positive sample
Time frame: through study completion, an average of 2 years
a test to determine the level or degree of ADA positive samples and analyse the effect on the plasma concentration.
Pharmacokinetics measurement A
Time frame: through study completion, an average of 2 year
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded. Peak Plasma Time (Tmax)
Pharmacokinetics measurement B
Time frame: through study completion, an average of 2 year
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded. Peak Plasma Concentration (Cmax)
Pharmacokinetics measurement C
Time frame: through study completion, an average of 2 year
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded. half-life time
Pharmacokinetics measurement D
Time frame: through study completion, an average of 2 year
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded. Mean Residence Time( MRT)
Pharmacokinetics measurement E
Time frame: through study completion, an average of 2 year
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded. Area under the plasma concentration versus time curve (AUC)
Pharmacokinetics measurement F
Time frame: through study completion, an average of 2 year
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded. elimination rate constant
Pharmacokinetics measurement G
Time frame: through study completion, an average of 2 year
According to the detection of the serum concentration of B003 in plasma sample, the diagram of drug concentration-time for individual and each dose group could be concluded. clearance rate(CL/F)
Therapeutic Efficacy A
Time frame: from date of start from the infusion of the first subject until the date after two treatments of the last subject, assessed up to 14 months.
Objective Remission Rate (ORR): to be defined as the percentage of patients with complete response or partial response. Patients with CR or PR for the first evaluation will be confirmed after 4weeks. Patients without any evaluations are regarded as none-response.
Therapeutic Efficacy B
Time frame: from date of start from the infusion of the first subject until the date after two treatments of the last subject, assessed up to 14 months.
Disease Control rate(DCR): to be defined as the percentage of patients with complete response, partial response or stable disease.
Therapeutic Efficacy C
Time frame: from the date when he patient has CR or PR to the first evaluation until the date when the patient has disease progression or death, assessed up to 14 months.
Duration of response(DOR): to be defined as the duration from the first evaluation time when the patient has CR or PR to the first evaluation time when the patient has disease progression or death.
Therapeutic Efficacy D
Time frame: from the date when he patient has CR or PR to the first evaluation until the date when the patient has disease progression or death, assessed up to 14 months.
Progression-free survival:to be defined as the duration from the time of first infusion to the first recording time when the patient has disease progression or death.
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 Sep 2023.
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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.
Yu Jiang principal investigator
West China Hospital
Yongsheng Wang principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003. in people with HER2-positive Breast Cancer, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site 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 7 inclusion and 18 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Maximum Tolerated Dose (time frame: through study completion, an average of 2 years). The study lists 15 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 Sep 2023.