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

NCT04164615 | Unknown Phase 3

• 1 other identifier: GENOR GB221-003；V1.1
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HER-2-positive Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival, PFS

  To evaluate the efficacy of GB221 as defined by progression-free survival in patients with breast cancer.

  through study completion, an average of 2 year

Secondary Outcomes (4)

• Objective Response Rate, ORR

  through study completion, an average of 2 year

• Antidrug antibody, ADA

  through study completion, an average of 2 year

• Overall survival, OS

  through study completion, an average of 2 year

• PFS in the extended treatment phase

  through study completion, an average of 2 year

Study Arms (2)

GB221+ Capecitabine tablets

EXPERIMENTAL

test drug+capecitabine

Drug: GB221

Placebo control + capecitabine tablets

PLACEBO COMPARATOR

placebo+capecitabine

Drug: Placebo control

Interventions

GB221 DRUG

GB221:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30\~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study. Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.

Also known as: Capecitabine

GB221+ Capecitabine tablets

Placebo control DRUG

Placebo control:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30\~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study. Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.

Also known as: capecitabine

Placebo control + capecitabine tablets

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 70 years;
• 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;
• HER-2 positive \[definition: including IHC (+++) or ISH positive; if IHC (++), HER-2 gene amplification detection should be further performed through fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH),silver-enhanced in situ hybridization (SISH) and other methods. The test reports of the clinical study site associated with the subject should be provided\];
• 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;
• The expected survival is 3 months or longer;
• The function of major organs such as heart, liver and kidney are basically normal;
• ECOG score ≤2;
• Understand and voluntarily sign the written informed consent form;

You may not qualify if:

• 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;
• Received radiotherapy or chemotherapy within 4 weeks before randomization;
• Received anti-tumor endocrine therapy within 2 weeks before randomization;
• Previously received the standard anti-HER-2 treatment;
• Previously received capecitabine treatment;
• Subjects who previously received no taxanes; or subjects who respond to taxanes (no disease progression or intolerable toxic reactions);
• 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:
• 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);
• Evidence showing severe or uncontrolled systemic diseases (e.g. unstable or non-compensated respiratory, cardiac, hepatic or renal disease);
• 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);
• Subjects who have any of the following cardiac conditions:

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

Study Sites (1)

People's Liberation Army General Hospital The Fifth Medical Center

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Shawn Yu, Master

CONTACT

18600332657; shawn.yu@genorbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: November 24, 2016
• Primary Completion: July 1, 2020
• Study Completion: November 1, 2020
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)