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New treatment option for HER2-positive Locally Advanced Resectable Gastric Cancer
Official title Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC
ClinicalTrials.gov ID: NCT06023758
What this study is testing
What is KN026?
KN026 is an investigational medicine, being studied as a potential treatment for her2-positive locally advanced resectable gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- The subject can understand the informed consent, voluntarily participate and sign the informed consent ;
- people 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;
You likely can't join 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...
- 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...
- Patients who have previously received other antibody/drug treatments for immune checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.
See the full eligibility criteria
- The subject can understand the informed consent, voluntarily participate and sign the informed consent ;
- people 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...
- 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...
- Life expectancy \>3 months;
- The people are able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.