Clinical Trial of Comparative Study of GB221 Pharmacokinetics

A Randomized, Double-blind, Parallel-group, Comparative Phase I Study to Evaluate the Safety and Pharmacokinetics of Single Intravenous (IV) Administration of GB221 Versus Herceptin® (Trastuzumab)

The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.

Study Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Drug: Coprelotamab Injection; Drug: Trastuzumab Injection

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Linear Clinical Research Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

To be enrolled in the study, subjects must meet the following criteria

1. Males aged 18 to 45 years.
2. Healthy as judged by medical examination and medical history, and clinical chemistry and hematology screening.
3. Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
4. Normal or non-clinically significant ECG.
5. Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate (40 -100 bpm, inclusive).
6. Willingness to give written and informed consent prior to any studyrelated procedures being conducted

Exclusion Criteria:

Subjects will be ineligible for the study if any of the following criteria apply:

1. Receipt of any investigational agent or drug within 4 weeks of entry to the study.
2. Use of any medicine - prescription, over-the-counter or herbal - in the 7 days prior to the treatment day and until 12 weeks after the treatment day.
3. Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
4. Clinically significant drug allergy or sensitivity to any medication.
5. A history of chronic or recurrent infections.
6. A recent history of surgery.
7. History or presence of malignancy (with the exception of successfully treated basal cell carcinoma).
8. Inability to communicate or cooperate with the Principal Investigator because of English language difficulties or poor mental development.
9. A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting tobacco use less than 10 cigarettes per day).
10. A positive urine test for drugs of abuse or alcohol either at screening or on the day of admittance for drug administration.
11. Vaccination of any type within the previous month.
12. A history of major psychiatric illness (such as bipolar disorder, schizophrenia or persistent major depression). Previous minor depression/adjustment disorder is acceptable if currently asymptomatic.
13. Consumption of more than 3 standard drinks per day, and not able to abstain from alcohol totally within 24 hours of dose administration.
14. Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.
15. History of asthma or other chronic respiratory disease in the past 5 years.
16. History of neurological or neuromuscular disease.
17. History of hypertension or cardiovascular disease, including congestive heart failure and cardiomyopathy or a clinically significant echocardiogram finding at the screening visit.
18. History of bladder or urethral disease.
19. Smoking cigarettes > 10 per day.
20. Any other condition which in the view of the Principal Investigator is likely to interfere with the study or put the subject at risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GB221; Coprelotamab Injection, 8mg/kg, single dose	Drug: Coprelotamab Injection; The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump.; Other Names: GB221
Active Comparator: Herceptin; Trastuzumab Injection, 8mg/kg, single dose	Drug: Trastuzumab Injection; The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump.; Other Names: Herceptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical examination	physical examination	Up to 84 days
adverse event	adverse event	Up to 84 days
blood pressure	blood pressure	Up to 84 days
heart rate	heart rate	Up to 84 days
respiration rate	respiration rate	Up to 84 days
oxygen saturation	oxygen saturation	Up to 84 days
temperature	temperature	Up to 84 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C max	C max	Up to 84 days
t max	t max	Up to 84 days
AUC	AUC	Up to 84 days
CL	CL	Up to 84 days
t ½	t ½	Up to 84 days
V	V	Up to 84 days

Collaborators and Investigators

• Sponsor: Genor Biopharma Co., Ltd.
• Investigators: Principal Investigator: Andrewn Redfer, PhD; MBBS, Linear Clinical Research Limited

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2011
• Primary Completion (Actual): January 8, 2012
• Study Completion (Actual): March 8, 2012

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: GB221-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No