Combination treatment for HER2-positive advanced gastric cancer
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.
This study is testing a new combination of two treatments for people with HER2-positive advanced stomach cancer to see if it works better than adding chemotherapy to the mix.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06023758 on ClinicalTrials.gov |
What this trial studies
This multicenter Phase 2 trial evaluates the efficacy of KN026 and KN046, two bispecific antibodies, in treating patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma. Participants will be divided into two groups; the first group will receive KN026 and KN046, while the second group will receive the same treatment combined with XELOX, a chemotherapy regimen. The study aims to assess the effectiveness of these combinations in blocking HER2 signaling and enhancing anti-tumor immune responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed locally advanced HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma.
Not a fit: Patients with severe comorbidities or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with HER2-positive gastric cancer.
How similar studies have performed: Other studies have shown promising results with similar bispecific antibody approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.