KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer

NCT03925974 | Completed Phase 2

• 1 other identifier: KN026-202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric/Gastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (2)

• ORR

  clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria

  1 years

• DOR

  clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria

  1 years

Study Arms (2)

HER2 overexpression

EXPERIMENTAL

HER2 IHC 3+ or IHC2+ and ISH+

Drug: KN026 10 mg/kg QW; Drug: KN026 20 mg/kg Q2W; Drug: KN026 30 mg/kg Q3W

HER2 expression

EXPERIMENTAL

HER2 IHC 2+ISH- or IHC 1+ and ISH+

Drug: KN026 10 mg/kg QW; Drug: KN026 20 mg/kg Q2W; Drug: KN026 30 mg/kg Q3W

Interventions

KN026 10 mg/kg QW DRUG

10 mg/kg QW as safety run-in dosage

HER2 expression; HER2 overexpression

KN026 20 mg/kg Q2W DRUG

20 mg/kg Q2W as target dosage

HER2 expression; HER2 overexpression

KN026 30 mg/kg Q3W DRUG

30 mg/kg Q3W as another target dosage

HER2 expression; HER2 overexpression

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Alphamab Biopharmaceuticals Co., Ltd: lead

Study Sites (1)

307 Hospital of PLA

Beijing, Beijing Municipality, 100071, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 24, 2019
• Study Start: June 17, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: March 12, 2024

Record last verified: 2023-11

Locations

CN (1)