KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer

Gastric/Gastroesophageal Junction Cancer Clinical Trial

Official title:

Phase II Study of Evaluating Efficacy, Safety and Tolerance of KN026 in HER2 Expressing Advanced Gastric/Gastroesophageal Junction Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925974
• Other study ID #: KN026-202
• Status: Completed
• Phase: Phase 2
• Start date: June 17, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2023
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.

Description:

The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Signed inform consent form(ICF)

• Age = 18 years and = 75 years, male or female

• Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ & ISH+ HER2 expressing: IHC2+ & ISH- or IHC 1+ & ISH+

• Received at least one prior standard therapy

• At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors(RECISIT) v 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ function

• LVEF= 50% (ECHO)

• Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.

• Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures

Exclusion Criteria:

• Accepted any other anti-tumor drug therapies within 4 weeks before fist dose

• Accepted radiotherapy within 4 weeks before enrollment

• An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines

• Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible

• Pregnant or nursing females;or intend pregnancy within this study period or within 6 monthes after the end of this study

• History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation

• Severe chronic and active infection, need to system antibiosis/antiviral treatment

• Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage

• Even with peripheral or central venous nutritional support, unintentional weight loss =5% within 1 month before the first medication

Related Conditions & MeSH terms

• Gastric/Gastroesophageal Junction Cancer

Intervention

Drug:
• KN026 10 mg/kg QW
10 mg/kg QW as safety run-in dosage
• KN026 20 mg/kg Q2W
20 mg/kg Q2W as target dosage
• KN026 30 mg/kg Q3W
30 mg/kg Q3W as another target dosage

Locations

Country	Name	City	State
China	307 Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria	1 years
Primary	DOR	clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria	1 years