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

NCT04170595 | Unknown Phase 1

• 1 other identifier: GENOR GB221-002
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody for injection for the treatment of HER2-positive breast cancer patients.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (9)

• maximum tolerated dose,MTD

  To evaluate the efficacy and safety of GB221.

  Up to 5 weeks

• C max

  C max

  Up to 5 weeks

• AUC (0- t)

  AUC (0- t)

  Up to 5 weeks

• AUC (0- ∞ )

  AUC (0- ∞ )

  Up to 5 weeks

• T max

  T max

  Up to 5 weeks

• T 1/2

  T 1/2

  Up to 5 weeks

• CL/F

  CL/F

  Up to 5 weeks

• V/F

  V/F

  Up to 5 weeks

• K e

  K e

  Up to 5 weeks

Secondary Outcomes (1)

• Antidrug antibody, ADA

  Up to 5 weeks

Study Arms (6)

GB221,2mg/kg

EXPERIMENTAL

Coprelotamab Injection, 2 mg/kg, Single dose,

Biological: GB221,2 mg/kg

GB221,6mg/kg

EXPERIMENTAL

Coprelotamab Injection, 6 mg/kg, Single dose,

Biological: GB221,6 mg/kg

Herceptin,6mg/kg

ACTIVE COMPARATOR

Trastuzumab Injection, 6 mg/kg, Single dose,

Biological: Herceptin,6 mg/kg

GB221,8mg/kg

EXPERIMENTAL

Coprelotamab Injection, 8 mg/kg, Single dose,

Biological: GB221,8mg/kg

GB221+ Capecitabine

EXPERIMENTAL

Multiple dose groups

Biological: GB221:2mg/kg and Capecitabi:1000mg/kg

Herceptin+Capecitabine

ACTIVE COMPARATOR

Multiple dose groups

Biological: Herceptin:2mg/kg and Capecitabin:1000mg/kg

Interventions

GB221,2 mg/kg BIOLOGICAL

Single dose, 2mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2 mg/kg for one dose, intravenous infusion, completed for over 90 minutes

Also known as: Coprelotamab Injection

GB221,2mg/kg

GB221,6 mg/kg BIOLOGICAL

Single dose 6mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes

Also known as: Coprelotamab Injection

GB221,6mg/kg

Herceptin,6 mg/kg BIOLOGICAL

Single dose group: lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes

Also known as: Trastuzumab Injection

Herceptin,6mg/kg

GB221,8mg/kg BIOLOGICAL

Single dose 8mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 8mg/kg for one dose, intravenous infusion, completed for over 90 minutes

Also known as: Coprelotamab Injection

GB221,8mg/kg

GB221:2mg/kg and Capecitabi:1000mg/kg BIOLOGICAL

GB221:Lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose group; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle.

GB221+ Capecitabine

Herceptin:2mg/kg and Capecitabin:1000mg/kg BIOLOGICAL

Herceptin:Lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose groups; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle.

Herceptin+Capecitabine

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 65 years;
• Histopathologically confirmed breast cancer;
• HER-2 positive (definition: the immunohistochemistry (IHC) test of pathological samples showed HER-2 +++ or immunohistochemistry (IHC) test showed HER-2 ++ and positive FISH amplification test);
• HER2-positive breast cancer patients who have no lesion after surgery and never received anti-HER-2 treatment;
• The investigators consider that the subject has recovered from the toxic reactions caused by the previous chemotherapy 4 weeks after the last chemotherapy.
• The expected survival is 3 months or longer;
• ECOG performance status is 0, 1 or 2;
• The left ventricular ejection fraction (LVEF)≥50%;
• The major organ function is normal and laboratory tests meet relevant criteria:
• l Hematology test:
• Hb≥90 g/L (no blood transfusion within 14 days);
• ANC≥1.5×109 /L;
• PLT≥100×109 /L; l Hepatic and renal function tests:
• TBIL≤1.5×ULN (upper limit of normal);
• ALT and AST≤2.5×ULN;

You may not qualify if:

• Pregnant or breastfeeding females; or women of childbearing potential who have positive urine pregnancy test; or any subjects who are able to bear or father a child but cannot or are unwilling to adopt medically acceptable effective contraceptive methods during the study period and within 3 months after the end of the study;
• 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;
• Serious uncontrolled arrhythmia;
• Any other cardiac diseases which may cause safety risks for patients if they are enrolled in this study;
• Uncontrolled hypertension (defined as screening systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥110mmHg);
• Known HIV, HBV or HCV infection;
• Allergic constitution; known allergic to the components of the investigational product;
• Have drug abuse history or alcohol addiction history;
• Participated in other clinical studies within 4 weeks before the initiation of the study;
• Have complicated diseases which may interfere with study participation or evaluation at the discretion of the investigator, e.g., uncontrolled infection, coagulation disorders and other diseases, or the investigators consider that participation in this study may lead to greater risks for patients.
• For multiple dose groups:

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

Study Sites (1)

Affiliated Hospital of Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ze Fei Jiang, Ph.D

  Affiliated Hospital of Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Yu, Master

CONTACT

18600332657; shawn.yu@genorbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 12, 2019
• First Posted: November 20, 2019
• Study Start: March 28, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)