Overview

Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection

Status:
Unknown status
Trial end date:
2020-11-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary objective is to evaluate the objective response rate (ORR),time to progression (TTP) from treatment period to week 12; overall survival (OS), safety, immunogenicity (anti-drug antibody), PFS of subjects during continued treatment period.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genor Biopharma Co., Ltd.
Treatments:
Antibodies
Antibodies, Monoclonal
Capecitabine
Criteria
Inclusion Criteria

1. Aged 18 to 70 years;

2. Pathologically confirmed as advanced breast cancer and there is at least one
measurable target lesion (based on RECIST V1.1):

l According to Response Evaluation Criteria in Solid Tumors, the target lesions must
be accurately measured in at least one dimension; l No previous radiotherapy,
intervention for target lesions;

3. HER-2 positive [definition: including IHC (+++) or ISH positive; if IHC (++), HER-2
gene amplification detection should be further performed through fluorescence in situ
hybridization (FISH) or chromogenic in situ hybridization (CISH),silver-enhanced in
situ hybridization (SISH) and other methods. The test reports of the clinical study
site associated with the subject should be provided];

4. The relapsed or metastatic patients who failed respond to the previous taxanes and/or
anthracyclines, previous first-line chemotherapy for the metastatic lesion is
acceptable;

5. The expected survival is 3 months or longer;

6. The function of major organs such as heart, liver and kidney are basically normal;

7. ECOG score ≤2;

8. Understand and voluntarily sign the written informed consent form;

2 Exclusion Criteria

1. Pregnant or breastfeeding females; or women of childbearing potential who have
positive serum/urine pregnancy tests; females of childbearing potential and their
partners are unwilling to adopt effective contraceptive methods during the clinical
study period and within 6 months after the end of the study;

2. Received radiotherapy or chemotherapy within 4 weeks before randomization;

3. Received anti-tumor endocrine therapy within 2 weeks before randomization;

4. Previously received the standard anti-HER-2 treatment;

5. Previously received capecitabine treatment;

6. Subjects who previously received no taxanes; or subjects who respond to taxanes (no
disease progression or intolerable toxic reactions);

7. The major organ function of subjects is abnormal. The laboratory test results are
presented below:

Hematology test:

l Absolute neutrophil count (ANC) < 1.5×109/L; l Platelet count (PLT) <100×109/L; l
Hemoglobin (Hb) < 90 g/L (no blood transfusion within 14 days);

Hepatic and renal function tests:

l Bilirubin (TBIL)>1.5×ULN (upper limit of normal); l Alanine aminotransferase (ALT) and
aspartate aminotransferase (AST)>2.5×ULN; if there is any hepatic metastasis, ALT and AST
>5×ULN; l Serum creatinine (Cr) >1.5×ULN; 8. Left ventricular ejection fraction (
LVEF)<50%; 9. The organ system status of subjects:

1 Subjects with known or suspected brain metastasis: subjects with evidence indicating
signs or symptoms of brain metastasis are not allowed to participate in this study unless
such brain metastasis is excluded by CT or MRI. However, subjects whose brain metastasis
lesions have been controlled can be enrolled (no progression within at least 4 weeks after
radiotherapy and/or no neurological symptom or sign after surgical resection, treatment
with dexamethasone or mannitol is not necessary);

1 Evidence showing severe or uncontrolled systemic diseases (e.g. unstable or
non-compensated respiratory, cardiac, hepatic or renal disease);

1 Uncontrolled active infection (≥CTCAE grade 2); l Any other malignant tumor within 5
years, excluding patients with completely cured cervical in situ carcinoma or basal cell or
squamous epithelial cell skin cancer);

1 Subjects who have any of the following cardiac conditions:

- Unstable angina pectoris;

- Medical history of congestive heart failure;

- Previous medical history of myocardial infarction, coronary artery bypass grafting or
coronary stent implantation;

- Clinically significant pericardial diseases and valvular heart diseases;

- Cardiac arrhythmias requiring therapeutic intervention;

- Any other cardiac diseases which may cause safety risks for subjects if they are
enrolled in this study; 1 Uncontrolled hypertension (defined as screening systolic
blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥110mmHg); 10.
Immunodeficiency medical history, including positive HIV detection; 11. Positive
hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA of peripheral blood is
not within the normal range; Positive hepatitis C virus antibody (HCV); 12. Subjects
with drug abuse history or alcohol addiction history; 13. Participated in clinical
study with drug intervention within one month before screening; 14. Subjects who are
unsuitable for participation in this study at the discretion of the investigators.