JSKN003 Combined Treatment of HER2-positive Gastric Cancer

NCT06998771 | Not Yet Recruiting Phase 2

• 1 other identifier: JSKN003-003
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HER2-positive Gastric Cancer

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR) of the first-line population

  Frame: Up to approximately 5 years

• Incidence and severity of TEAE and SAE of the first-line population

  Up to approximately 5 years

• pCR rate after neoadjuvant therapy of perioperative population

  Up to approximately 5 years

Secondary Outcomes (16)

• Disease Control Rate (DCR) of the first-line population

  Up to approximately 5 years

• Duration of Response (DoR) of the first-line population

  Up to approximately 5 years

• Progression-free survival (PFS) of the first-line populations

  Up to approximately 5 years

• Major pathological response (MPR) rate of perioperative population

  Up to approximately 5 years

• R0 rate of perioperative population

  Up to approximately 5 years

Study Arms (4)

Combination of JSKN003 and capecitabine with or without enlonstobart

EXPERIMENTAL

Drug: JSKN003; Drug: Capecitabine; Drug: Enlonstobart

Combination of JSKN003, capecitabine and KN026 with or without enlonstobart

EXPERIMENTAL

Drug: JSKN003; Drug: KN026; Drug: Capecitabine; Drug: Enlonstobart

Combination of JSKN003, capecitabine and oxaliplatin with or without enlonstobart

EXPERIMENTAL

Drug: JSKN003; Drug: Capecitabine; Drug: Enlonstobart; Drug: Oxaliplatin

Combination of trastuzumab, capecitabine and oxaliplatin with or without pembolizumab

EXPERIMENTAL

Drug: Capecitabine; Drug: Oxaliplatin; Drug: Trastuzumab; Drug: Pembolizumab

Interventions

JSKN003 DRUG

JSKN003 is administered by intravenous infusion.

Combination of JSKN003 and capecitabine with or without enlonstobart; Combination of JSKN003, capecitabine and KN026 with or without enlonstobart; Combination of JSKN003, capecitabine and oxaliplatin with or without enlonstobart

KN026 DRUG

KN026 is administered by intravenous infusion.

Combination of JSKN003, capecitabine and KN026 with or without enlonstobart

Capecitabine DRUG

Capecitabine is for oral administration.

Combination of JSKN003 and capecitabine with or without enlonstobart; Combination of JSKN003, capecitabine and KN026 with or without enlonstobart; Combination of JSKN003, capecitabine and oxaliplatin with or without enlonstobart; Combination of trastuzumab, capecitabine and oxaliplatin with or without pembolizumab

Enlonstobart DRUG

Enlonstobart is administered by intravenous infusion.

Combination of JSKN003 and capecitabine with or without enlonstobart; Combination of JSKN003, capecitabine and KN026 with or without enlonstobart; Combination of JSKN003, capecitabine and oxaliplatin with or without enlonstobart

Oxaliplatin DRUG

Oxaliplatin is administered by intravenous infusion.

Combination of JSKN003, capecitabine and oxaliplatin with or without enlonstobart; Combination of trastuzumab, capecitabine and oxaliplatin with or without pembolizumab

Trastuzumab DRUG

Trastuzumab is administered by intravenous infusion.

Combination of trastuzumab, capecitabine and oxaliplatin with or without pembolizumab

Pembolizumab DRUG

Pembolizumab is administered by intravenous infusion.

Combination of trastuzumab, capecitabine and oxaliplatin with or without pembolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participants with PD-L1CPS ≥1, who have an active autoimmune disease or have a history of autoimmune disease 2 years before the first dose or randomization and still require systemic treatment. However, participant with the following diseases is allowed to enroll: well-controlled type I diabetes, well-controlled hypothyroidism that requires hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or hair loss), or participant who is expected to not recur without external triggers.
• Participate in another clinical trial, unless it is an observational (non-intervention) clinical trial or is in the follow-up period of an intervention trial.
• Participants who have undergone major surgery or had invasive intervention within 28 days before the first dose or randomization. Or those who plan to undergo systematic or local tumor resection during the trial (Perioperative cohort does not apply).
• Any Chinese patent medicine with anti-cancer activity approved by the National Drug Administration (regardless of cancer type) has been used within 14 days before the first dose or randomization.
• Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
• Active bacterial, fungal or viral infection before the first dose or randomization. Participant who has recieved preventive infection treatment but has no clinical manifestations before the first dose or randomization could be considered to enroll.
• Has a history of immunodeficiency, including HIV-positive.
• Active hepatitis B or C infection. Participant with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) need to test Hepatitis B virus DeoxyriboNucleic Acid (HBV-DNA), and HBV-DNA is higher than 500 IU/mL (or 2500 copies/ml) or upper limit of normal (UNL) (whichever is lower) ; Participants with positive for hepatitis C (HCV) antibody and whose Hepatitis C virus Ribonucleic Acid (HCV-RNA) is higher than 1000 copies/ml or UNL (whichever is lower).
• Has a history of tuberculosis treatment within 2 years before the first dose or randomization.
• Has activity or a history of interstitial lung disease at any stage and/or pulmonary function injury, a history of interstitial pneumonia requiring hormone therapy, or the imaging cannot rule out suspected interstitial lung disease/pneumonia at screening.
• Known to have low activity or lack of dihydropyrimidine dehydrogenase (DPD).

Sponsors & Collaborators

• Shanghai JMT-Bio Inc.: lead

MeSH Terms

Interventions

Capecitabine; Oxaliplatin; Trastuzumab

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 31, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 31, 2025

Record last verified: 2025-05