JSKN003 Combined Treatment of HER2-positive Gastric Cancer
ConditionHER2-positive Gastric Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai JMT-Bio Inc.
About this trial
This study is designed to evaluate the safety and efficacy of JSKN003 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer or resectable gastric cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥18 years old.
Histologically or cytologically confirmed diagnosis of gastric cancer.
The first-line population enrolls participants with HER2-positive unresectable locally advanced or metastatic gastric cancer who had not received systemic treatment, and Perioperative population enrolls participants with HER2-positive resectable gastric cancer who had not received treatment.
HER2-positive (defined as IHC3+ or IHC 2+/FISH +).
Disqualifiers
Has received anti-tumor treatment such as systemic chemotherapy or other trial interventions within 28 days, or immunotherapy (e.g. interleukin, interferon, thymospipeptide, etc.), hormone therapy or targeted therapy within 14 days or 5 half-life (whichever is shorter) before the first dose or randomization.
Has previously been treated with an anti-HER2 ADC loaded with topoisomerase I inhibitors.
Participants with brain metastasis or spinal cord compression at screening (except for completed local treatment and discontinued glucocorticoids for at least 4 weeks before the first dose or randomization , and stable central nervous system imaging and brain metastasis symptoms for at least 4 weeks).
Participants with PD-L1 CPS ≥1, who are receiving long-term immunotherapy (e.g., cyclosporine) or require daily systemic steroid therapy (e.g., >20 mg prednisone or equivalent), except those who treated with local glucocorticoids using nasal spray, inhalation, or other pathways.
Trial design
Design model
Parallel
Treatments tested in this trial
JSKN003
DrugJSKN003 is administered by intravenous infusion.
KN026
DrugKN026 is administered by intravenous infusion.
Capecitabine
DrugCapecitabine is for oral administration.
Enlonstobart
DrugEnlonstobart is administered by intravenous infusion.
Oxaliplatin
DrugOxaliplatin is administered by intravenous infusion.
Trastuzumab
DrugTrastuzumab is administered by intravenous infusion.
Pembolizumab
DrugPembolizumab is administered by intravenous infusion.
Treatment groups
153 Participants
are divided into 4 treatment groupsGroup A: Combination of JSKN003 and capecitabine with or without enlonstobartExperimental treatment 3 interventions
Group B: Combination of JSKN003, capecitabine and KN026 with or without enlonstobartExperimental treatment 4 interventions
Group C: Combination of JSKN003, capecitabine and oxaliplatin with or without enlonstobartExperimental treatment 4 interventions
Group D: Combination of trastuzumab, capecitabine and oxaliplatin with or without pembolizumabExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR) of the first-line population
Time frame
Frame: Up to approximately 5 years2
Incidence and severity of TEAE and SAE of the first-line population
Time frame
Up to approximately 5 years3
pCR rate after neoadjuvant therapy of perioperative population
Time frame
Up to approximately 5 yearsSecondary outcomes
1
Disease Control Rate (DCR) of the first-line population
Time frame
Up to approximately 5 years2
Duration of Response (DoR) of the first-line population
Time frame
Up to approximately 5 years3
Progression-free survival (PFS) of the first-line populations
Time frame
Up to approximately 5 years4
Major pathological response (MPR) rate of perioperative population
Time frame
Up to approximately 5 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: