JSKN003 Combined Treatment of HER2-positive Gastric Cancer (NCT06998771) | Clinical Trial Compass
Not Yet RecruitingPhase 2
JSKN003 Combined Treatment of HER2-positive Gastric Cancer
153 participantsStarted 2025-06-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 +).
* The first-line population: presence of at least 1 measurable lesion per RECIST 1.1. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* ECOG PS of 0 - 1.
* Expected survival ≥ 3 months.
* Participants with adequate organ functions.
* Female and male patients of childbearing age agree to take adequate contraceptive measures during and upon completion of the study for 7 months after the last dose. Female participants of childbearing age must have a negative blood pregnancy test within 7 days before the first dose or randomization.
* Voluntarily agree to participate in the study and sign the informed consent.
Exclusion Criteria:
* 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.
* H…
What they're measuring
1
Objective Response Rate (ORR) of the first-line population
Timeframe: Frame: Up to approximately 5 years
2
Incidence and severity of TEAE and SAE of the first-line population
Timeframe: Up to approximately 5 years
3
pCR rate after neoadjuvant therapy of perioperative population