Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC

NCT06023758 | Recruiting Phase 2

• 1 other identifier: KHER2-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma.

Conditions

HER2-positive Locally Advanced Resectable Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• pCR rate

  Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)

  up to 2 years

Secondary Outcomes (3)

• Event-free survival (EFS)

  from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years

• Disease-free survival (DFS)

  from the start of surgery to disease recurrence or death (for any reason)，assessed up to 3 years

• overall survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 5 years

Study Arms (2)

KN026 combined with KN046

EXPERIMENTAL

KN026 combined with KN046

Drug: KN026; Drug: KN046

KN026，KN046 and XELOX

EXPERIMENTAL

KN026，KN046 and XELOX

Drug: KN026; Drug: KN046; Drug: XELOX

Interventions

KN026 DRUG

KN026：30 mg/kg Q3W

KN026 combined with KN046; KN026，KN046 and XELOX

KN046 DRUG

KN046：5 mg/kg Q3W

KN026 combined with KN046; KN026，KN046 and XELOX

XELOX DRUG

Oxaliplatin 130mg/m2 d1，Capecitabine 1000mg/m2 d1-14，Q3W

KN026，KN046 and XELOX

Eligibility Criteria

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

You may qualify if:

• The subject can understand the informed consent, voluntarily participate and sign the informed consent ;
• Subjects are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent；
• Histologically or cytologically confirmed, locally advanced HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma.
• ECOG score 0 or 1;
• Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO (preferred) or MUGA;
• Liver function met the following criteria within 7 days prior to initial administration:
• Total bilirubin ≤1.0x ULN (Gilbert's syndrome, or total bilirubin ≤1.5x ULN in liver metastases); Aminotransferase (ALT/AST) ≤1.5x ULN (liver metastatic subjects ≤3xULN); -Renal function within 7 days prior to initial administration: serum creatinine ≤1.5x ULN and serum creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation);
• Bone marrow function met the following criteria within 7 days prior to initial administration: Hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5 x 109/L; Platelet count ≥100x 109/L; INR or PT≤1.5x ULN, and aPTT≤ 1.5x ULN;
• Life expectancy \>3 months;
• The subjects are able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol

You may not qualify if:

• Existence of other active malignant tumors within 5 years or at the same time. Plan to perform or have undergone an organ or bone marrow transplant. Myocardial infarction and poorly controlled arrhythmias occurred within 6 months prior to the first dose.
• Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram shows: LVEF (left ventricular ejection fraction) \< 50%.
• Human immunodeficiency virus (HIV) infection.
• Patients with active tuberculosis.
• Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
• Patients who have previously received other antibody/drug treatments for immune checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.
• Have diseases that may increase the risk of participating in the study and using the study medications, or other severe, acute, and chronic diseases and therefore are judged by the investigator to be unsuitable for clinical studies.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

XELOX

Study Design

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

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 5, 2023
• Study Start: September 22, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 10, 2024

Record last verified: 2023-08

Locations

CN (1)