OncoMatch/Clinical Trials/NCT05427383
KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy
Is NCT05427383 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including KN026/Placbo and Paclitaxel for stomach cancer.
Treatment: KN026/Placbo · Paclitaxel · Docetaxel · Irinotecan — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Gastric Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
HER2 positive is defined as IHC 3+
Required: HER2 (ERBB2) overexpression (IHC 2+ with ISH test positive (HER2/CEP17 ratio ≥ 2.0, or mean HER2 copy number ≥ 6.0 signals/cell))
HER2 positive is defined as IHC 2+ with ISH test positive (HER2/CEP17 ratio ≥ 2.0, or mean HER2 copy number ≥ 6.0 signals/cell)
Excluded: MSI highly unstable microsatellite (MSI-H)
highly unstable microsatellite (MSI-H) without previous PD-1/PD-L1 monoclonal antibody therapy
Excluded: Mismatch-repair deficient (MSI-H / dMMR)
Known mismatch repair deficient (dMMR) ... without previous PD-1/PD-L1 monoclonal antibody therapy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: trastuzumab plus chemotherapy (trastuzumab) — first-line
Failure of at least first-line standard therapy (trastuzumab plus chemotherapy); Note: Neoadjuvant/adjuvant therapy previously administered with a trastuzumab-containing regimen can be considered first-line therapy if the subject has progressed disease during neoadjuvant/adjuvant therapy or within 6 months of completion of treatment
Cannot have received: anti-HER2 therapy other than trastuzumab
Previous use of anti-HER2 therapy other than trastuzumab (eg, ADC, dual-antibody, small molecule targeted therapy, etc.)
Cannot have received: anthracycline (doxorubicin, epirubicin, pyrrubicin, daunorubicin, normethoxydaunorubicin, mitoxantrone)
Exception: except doxorubicin liposomes
Previous cumulative doses of doxorubicin exceeding 320 mg/m^2, or equivalent conversion of other anthracyclines ... except doxorubicin liposomes
Lab requirements
Blood counts
Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil (ANC) ≥ 1.5×10^9/L; Platelet (PLT) ≥ 90×10^9/L; (No whole blood or component blood transfusion in the last 14 days; no pro-hematopoietic cytokines used in the last 7 days)
Kidney function
creatinine clearance ≥ 50 mL/min (standard Cockcroft-Gault formula applied)
Liver function
AST, ALT ≤2.5× ULN (if liver metastases, AST, ALT ≤5×ULN); Total bilirubin (TBIL) ≤1.5×ULN; Albumin≥ 28 g/L
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% or lower limit of normal (LLN) in local sites, measured by echocardiography (ECHO), cardiac radionuclide scanning (MUGA) only in the absence of ECHO, with consistency at baseline and follow-up measurements; APTT ≤ 1.5×ULN, INR/or PT ≤ 1.5×ULN
The function of major organs must meet the following criteria : Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil (ANC) ≥ 1.5×10^9/L; Platelet (PLT) ≥ 90×10^9/L; (No whole blood or component blood transfusion in the last 14 days; no pro-hematopoietic cytokines used in the last 7 days); AST, ALT ≤2.5× ULN (upper limit of normal value) (if liver metastases, AST, ALT ≤5×ULN); Total bilirubin (TBIL) ≤1.5×ULN; Albumin≥ 28 g/L; creatinine clearance ≥ 50 mL/min (standard Cockcroft-Gault formula applied); Activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR)/or prothrombin time (PT) ≤ 1.5×ULN; ... Left ventricular ejection fraction (LVEF) ≥ 50% or lower limit of normal (LLN) in local sites, measured by echocardiography (ECHO), cardiac radionuclide scanning (MUGA) only in the absence of ECHO, with consistency at baseline and follow-up measurements
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05427383 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-HER2 therapy other than trastuzumab, anthracycline disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Are patients with MLH1 alterations eligible?
No. MLH1 deficient mismatch repair is an exclusion criterion.
Are patients with MSH2 alterations eligible?
No. MSH2 deficient mismatch repair is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages