Clinical trial · Interventional
KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer
Phase II Study of Evaluating Efficacy, Safety and Tolerance of KN026 in HER2 Expressing Advanced Gastric/Gastroesophageal Junction Cancer
NCT03925974CI-TRIAL-00074952completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric/Gastroesophageal Junction Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KN026 10 mg/kg QW | Drug | — | UNRESOLVED |
| KN026 20 mg/kg Q2W | Drug | — | UNRESOLVED |
| KN026 30 mg/kg Q3W | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HER2 overexpression
- description
- HER2 IHC 3+ or IHC2+ and ISH+
- interventionNames
- Drug: KN026 10 mg/kg QW
- Drug: KN026 20 mg/kg Q2W
- Drug: KN026 30 mg/kg Q3W
- type
- EXPERIMENTAL
- label
- HER2 expression
- description
- HER2 IHC 2+ISH- or IHC 1+ and ISH+
- interventionNames
- Drug: KN026 10 mg/kg QW
- Drug: KN026 20 mg/kg Q2W
- Drug: KN026 30 mg/kg Q3W
Primary outcomes (2)
- measure
- ORR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Signed inform consent form(ICF) * Age ≥ 18 years and ≤ 75 years, male or female * Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ \& ISH+ HER2 expressing: IHC2+ \& ISH- or IHC 1+ \& ISH+ * Received at least one prior standard therapy * At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors(RECISIT) v 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function * LVEF≥ 50% (ECHO) * Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed. * Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures Exclusion Criteria: * Accepted any other anti-tumor drug therapies within 4 weeks before fist dose * Accepted radiotherapy within 4 weeks before enrollment * An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines * Subjects are eligible with clinically controlled and stable neurologic function \>= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible * Pregnant or nursing females;or intend pregnancy within this study period or within 6 monthes after the end of this study * History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation * Severe chronic and active infection, need to system antibiosis/antiviral treatment * Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage * Even with peripheral or central venous nutritional support, unintentional weight loss ≥5% within 1 month before the first medication
References
Publications (0)
Data not yet available
No reference posted for this study.