Actively Recruiting
KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy
Led by Shanghai JMT-Bio Inc. · Updated on 2023-12-19
286
Participants Needed
1
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together. Randomized stage is designed to evaluate the OS and PFS in patients receiving KN026 and chemotherapy compared to patients receiving placebo and chemotherapy.
CONDITIONS
Official Title
KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- HER2-positive locally advanced, recurrent, or metastatic gastric cancer including gastro-esophageal junction adenocarcinoma confirmed by biopsy
- HER2 positivity defined as IHC 3+, or IHC 2+ with positive ISH test
- Failed at least first-line standard therapy including trastuzumab plus chemotherapy
- At least one measurable (stage 1) or evaluable (stage 2) lesion per RECIST 1.1 criteria
- ECOG Performance Status of 0 to 1
- Life expectancy of 3 months or more
- Adequate major organ function including hemoglobin ≥ 90 g/L, neutrophils ≥ 1.5x10^9/L, platelets ≥ 90x10^9/L, liver enzymes within specified limits, albumin ≥ 28 g/L, creatinine clearance ≥ 50 mL/min, and coagulation parameters within limits
- Left ventricular ejection fraction ≥ 50% or lower limit of normal
- Agreement to use effective contraception during study and for 6 months after last dose
- Ability and willingness to comply with study protocol
You will not qualify if you...
- Untreated active brain metastases; stable treated brain metastases allowed under specific conditions
- Use of other investigational drugs within 4 weeks before study treatment
- Antineoplastic therapy including chemo, immunotherapy, or herbal antitumor treatment within defined prior periods
- Major surgery within 28 days before study treatment or planned major surgery during study
- Prior cumulative doxorubicin dose exceeding 320 mg/m^2 or equivalent anthracycline doses
- Previous anti-HER2 therapies other than trastuzumab
- Pregnant or breastfeeding women or those planning pregnancy during or within 6 months after study
- Severe allergies to protein drugs or KN026 components
- Unresolved adverse events from prior anti-tumor treatments except alopecia and skin pigmentation
- Uncontrolled diarrhea grade 2 or higher not improving within 48 hours
- Significant cardiovascular diseases including uncontrolled hypertension, heart failure, recent myocardial infarction, severe arrhythmias, abnormal QT intervals, or other serious heart conditions
- Poorly controlled systemic diseases including diabetes
- Severe or active infections requiring continued systemic treatment
- Recent systemic corticosteroid use exceeding 10 mg/day prednisone equivalent within 2 weeks
- History of noninfectious interstitial lung disease requiring hormonal therapy
- Immunodeficiency including HIV or prior organ transplantation
- Active hepatitis B or C infection or confirmed HIV or syphilis infection
- Other malignant tumors within 5 years except certain cured or low-risk cancers
- Effusions requiring drainage or diuretics within 2 weeks before treatment
- Known mismatch repair deficiency or high microsatellite instability without prior PD-1/PD-L1 therapy
- Unintentional weight loss of 5% or more within 1 month despite nutritional support
- Inability or refusal to tolerate required chemotherapy
- Investigator judgment of unsuitability due to clinical or lab abnormalities or systemic disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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