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Recurrent Breast CancerPhase 1B002-101NCT04382352

B002 in Patients With HER2-positive Breast Cancer

A Phase 1 study testing Humanized Anti-HER2 Monoclonal Antibody Compound for Injection .R&D code: B002. in people with Recurrent Breast Cancer and Metastatic Breast Cancer, run by Shanghai Pharmaceuticals Holding Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess the safety and tolerability characteristics of B002 in patients with HER2-positive recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) was assessed and the maximum tolerated dose (MTD) was explored. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Humanized Anti-HER2 Monoclonal Antibody Compound for Injection .R&D code: B002.
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteChina
Study dates
28 May 2019to 26 Apr 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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years old ≤ age ≤ 70 years old, female;
  • BMI 18 ~ 32 kg / m2, including both ends;
  • Histological or cytologically confirmed recurrent or metastatic breast cancer. According to RECIST v 1.1, patients with measurable and/or unmeasurable lesions:
  • Patients with bone metastases, as long as the bone metastases have never received radiotherapy, and the primary tumor tumours are available for HER2 detection and Biomarker analysis, which can be enrolled;
  • Patients with local recurrence and unsuitable for radical mastectomy;
  • For bilateral breast cancer, and bilateral HER2 expression is inconsistent, the metastases should be confirmed to be HER2 positive;
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  • Anti-HER2 treatment failure for recurrent or metastatic disease;
  • A retrograde or metastatic breast cancer diagnosed as HER2 positive (FISH positive and / or IHC 3+) by the Department of Pathology diagnosis;
  • The left ventricular ejection fraction (LVEF) was detected by echocardiography (ECHO) ≥50% in the baseline period (28 days before the start of the trial);
  • ECOG physical state (PS) is 0-1 points;
  • Expected to survive for more than 3 months;
  • 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;
  • Understand and voluntarily sign the informed consent form.

Who cannot join

  • In the screening examination, the blood concentration of patients who have used pertuzumab in the past is ≥5μg/ml;
  • In the screening examination, the blood concentration of patients who have used trastuzumab in the past is ≥5μg/ml;
  • Known to be allergic to the study drug or its components;
  • Subjects with a history of contrast allergies;
  • There is clinical or radiological evidence of a central nervous system (CNS) metastasis. For patients with clinically suspected CNS metastases, enhanced CT or enhanced MRI must be performed within the first 28 days of randomization to exclude CNS metastasis;
  • Hematological toxicity caused by previous treatment CTCAE ≥ 2 persistence (except hemoglobin) (NCI-CTCAE version 4.03);
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  • There are peripheral neuropathy CTCAE ≥ 3 (first dose group, peripheral neuropathy CTCAE ≥ 2);
  • A history of other malignancies in the last 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma or squamous cell carcinoma of the skin;
  • Uncontrolled high blood pressure (systolic blood pressure greater than 150 mmHg and / or diastolic blood pressure greater than 100 mmHg), orthostatic hypotension;
  • Cardiac standard: QTc>480ms. There are factors that can cause QTc prolongation or arrhythmia such as congestive heart failure, hypokalemia, long QT syndrome (atrial fibrillation, paroxysmal supraventricular tachycardia). There are any unstable cardiovascular diseases (including the New York Heart Association NYHA cardiac function grade III or IV, congestive heart failure, unstable angina, a history of myocardial infarction within 6 months);
  • LVEF <50% during the period of neoadjuvant or adjuvant therapy or prior to the end of treatment with trastuzumab or pertuzumab for injection;
  • Resting dyspnea caused by complications of advanced malignancies, or other conditions requiring continuous oxygen therapy;
  • There are serious, uncontrollable systemic diseases (such as clinically significant cardiovascular, pulmonary, liver and kidney, digestive or metabolic diseases; fractures);
  • Experience major surgery or trauma within 28 days prior to the start of the trial, or plan for major surgery before the end of the study treatment;
  • The cumulative dose of anthracycline antibiotics was assessed at baseline (within 28 days prior to the start of the trial) to meet the following criteria:
  • doxorubicin > 360 mg/m2;
  • epirubicin > 720 mg/m2;
  • hydrochloric acid mitoxantrone > 120 mg/m2 and idarubicin (demethoxy daunorubicin) > 90 mg/m2;
  • other (such as doxorubicin liposome or other anthracycline antibiotics > 360 mg / Doxorubicin equivalent dose of m2);
  • If more than one anthracycline antibiotic is used, the cumulative dose should not exceed the equivalent dose of doxorubicin of 360 mg/m2;
  • Have received any trial medication within 28 days prior to the start of the trial;
  • Have received any therapeutic antibody or vaccine within 28 days prior to the start of the trial;
  • Chemotherapy, endocrine therapy, and radiotherapy were administered within 28 days prior to the start of the trial;
  • Intravenous infusion of antibiotics to treat infection within 14 days prior to the start of the trial;
  • Daily oral glucocorticoid treatment, equivalent to a dose of >10 mg / day of methylprednisolone, except for inhaled corticosteroids;
  • The presence of anti-drug antibodies against trastuzumab or pertuzumab;
  • Within 7 days prior to the start of the trial, laboratory tests revealed any of the following abnormalities:
  • Absolute count of neutral cells <1.5×109/L;
  • Platelet count <80.0×109/L;
  • Hemoglobin <9 g/dL;
  • Total Bilirubin > 1.5 × normal upper limit (ULN) (unless the patient has Glibert's syndrome)
  • AST or ALT > 2.5 × ULN
  • Creatinine clearance (calculated using the Cockcroft_Gault formula) < 50 mL / min
  • International normalized ratio (INR) and Activated partial thromboplastin time or partial thromboplastin time (APPT or PT) > 1.5 x ULN (unless treated for coagulation abnormalities);
  • Hepatitis B surface antigen positive and HBV-DNA test ≥ lower limit of detection; hepatitis C antibody positive; HIV antibody positive;
  • Pregnant or lactating women;
  • Other circumstances judged by the investigator are not suitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Experimental Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of B002 in the Treatment of HER2-positive Recurrent or Metastatic Breast Cancer.

To assess the safety and tolerability characteristics of B002 in patients with HER2-positive recurrent or metastatic breast cancer. The dose-limiting toxicity (DLT) was assessed and the maximum tolerated dose (MTD) was explored.

Being tested
Humanized Anti-HER2 Monoclonal Antibody Compound for Injection .R&D code: B002.
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Humanized Anti-HER2 Monoclonal Antibody Compound for Injection .R&D code: B002.Biological

    Also called Biological Products, Humanized Anti-HER2 Monoclonal Antibody Compound for Injection

    Usage: intravenous infusion; B002, doses 2, 6, 12, 16, 20 mg / kg, intravenous drip. The infusion time was 120 ± 10 minutes for the first time; if the patient was tolerated, the follow-up time was adjusted to 60 ± 10 minutes. Pre-treatment was performed using phenergan (25 mg, intramuscular) within 30 minutes prior to each study drug infusion. The dosing cycle is administered once every 3 weeks for one cycle and can be administered continuously until the disease progresses or is intolerable.

Study groups in NCT04382352
Study groupRoleWhat they receive
Humanized Anti-HER2 Monoclonal Antibody Compound for InjectionExperimentalRegistration number: CTR20181455 Indications: HER2-positive recurrent or metastatic breast cancer Experimental popular topic: Phase Ia clinical study of recombinant anti-HER2 humanized monoclonal antibody composition
Receives: Biological: Humanized Anti-HER2 Monoclonal Antibody Compound for Injection .R&D code: B002.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Tolerated Dose (MTD)

    Measured: 21 days

  2. Dose-Limiting Toxicity (DLT)

    Measured: 21 days

Secondary outcomes (5)

  1. Tmax

    Pharmacokinetics measurement

    Measured: 21 days

  2. Cmax

    Pharmacokinetics measurement

    Measured: 21 days

  3. AUC

    Pharmacokinetics measurement

    Measured: 21 days

  4. Anti-drug antibody (ADA)

    Measured: through study completion, an average of 2 years

  5. Objective Remission Rate (ORR)

    Therapeutic Efficacy

    Measured: through study completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2020
  2. Study start28 May 2019
  3. Primary completion26 Apr 2022
  4. Study completion26 Apr 2022

Resources

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
Test staging: Phase I Design Type: Single Arm Test This study was a preliminary study of stage Ia, openness, dose escalation, pharmacokinetics, and efficacy. To assess safety and tolerability in HER2-positive recurrent or metastatic breast cancer subjects, to determine dose-limiting toxicity (DLT) and to explore maximum tolerated dose (MTD); to evaluate pharmacokinetic characteristics, immunization Originality and preliminary exploration of efficacy. The study was divided into the main trial period and the extended trial period. The subject trial completed the enrollment and DLT observations of all evaluable DLT subjects for the dose climbing phase; the PK expansion phase completed the enrollment required PK sample collection for the enrolled subjects. The extension test is the completion of the subject test and the subject continues to take the drug to the stage of progression of the disease or intolerance. Blind method: open Test range: Domestic test
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04382352
Sponsor's protocol ID
B002-101
Acronym
B002-101
Status last verified
Oct 2022
First submitted
29 Apr 2020
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Humanized Anti-HER2 Monoclonal Antibody Compound for Injection .R&D code: B002. in people with Recurrent Breast Cancer and Metastatic 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 13 inclusion and 37 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 24 Mar 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 (MTD) (time frame: 21 days). The study lists 2 primary outcomes in all. 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 NCT04382352.

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 24 Mar 2023.

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