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HER2-positive Gastric CancerPhase 2NCT06998771

JSKN003 Combined Treatment of HER2-positive Gastric Cancer

A Phase 2 study testing JSKN003, KN026 and Capecitabine in people with HER2-positive Gastric Cancer, run by Shanghai JMT-Bio Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-positive Gastric Cancer
What is being tested?
JSKN003, KN026 and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
No sites listed yet
Study dates
15 Jun 2025to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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).
  • Participants with peripheral neuropathy of grade > 1.
  • Participants with clinically significant gastrointestinal diseases including but not limited to severe liver diseases, ulcerative colitis, inflammatory bowel disease and other gastrointestinal diseases 28 days before the first dose or randomization.
  • Has a history of severe cardiovascular disease.
  • History of any other malignant tumors within 5 years before the first dose or randomization.
  • Live vaccination within 28 days before the first dose or randomization. Note: Seasonal influenza vaccine is a broadly inactivated vaccine and is allowed to be used;
  • Unable to swallow orally, or there are conditions that have been judged by researchers to seriously affect gastrointestinal absorption (such as severe Crohn's disease, malabsorption syndrome, etc.).
  • Pregnant or breastfeeding women.
  • Otherwise considered inappropriate for the study by the investigator.

About this study

Official title: A Phase II Trial 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

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.

Being tested
JSKN003, KN026, Capecitabine, Enlonstobart, Oxaliplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JSKN003Drug

    JSKN003 is administered by intravenous infusion.

  • KN026Drug

    KN026 is administered by intravenous infusion.

  • CapecitabineDrug

    Capecitabine is for oral administration.

  • EnlonstobartDrug

    Enlonstobart is administered by intravenous infusion.

  • OxaliplatinDrug

    Oxaliplatin is administered by intravenous infusion.

  • TrastuzumabDrug

    Trastuzumab is administered by intravenous infusion.

  • PembolizumabDrug

    Pembolizumab is administered by intravenous infusion.

Study groups in NCT06998771
Study groupRoleWhat they receive
Combination of JSKN003 and capecitabine with or without enlonstobartExperimentalNot described
Receives: Drug: JSKN003; Drug: Capecitabine; Drug: Enlonstobart
Combination of JSKN003, capecitabine and KN026 with or without enlonstobartExperimentalNot described
Receives: Drug: JSKN003; Drug: KN026; Drug: Capecitabine; Drug: Enlonstobart
Combination of JSKN003, capecitabine and oxaliplatin with or without enlonstobartExperimentalNot described
Receives: Drug: JSKN003; Drug: Capecitabine; Drug: Enlonstobart; Drug: Oxaliplatin
Combination of trastuzumab, capecitabine and oxaliplatin with or without pembolizumabExperimentalNot described
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Trastuzumab; Drug: Pembolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Frame: Up to approximately 5 years

  2. Incidence and severity of TEAE and SAE of the first-line population

    Measured: Up to approximately 5 years

  3. pCR rate after neoadjuvant therapy of perioperative population

    Measured: Up to approximately 5 years

Secondary outcomes (16)

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

    Measured: Up to approximately 5 years

  2. Duration of Response (DoR) of the first-line population

    Measured: Up to approximately 5 years

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

    Measured: Up to approximately 5 years

  4. Major pathological response (MPR) rate of perioperative population

    Measured: Up to approximately 5 years

  5. R0 rate of perioperative population

    Measured: Up to approximately 5 years

  6. Event-free survival (EFS) of perioperative population

    Measured: Up to approximately 5 years

  7. Overall Survival (OS)

    Measured: Up to approximately 5 years

  8. Incidence and severity of AE

    Measured: Up to approximately 5 years

  9. Blood concentration of JSKN003

    Measured: Up to approximately 2 years

  10. Blood concentration of total antibodies for JSKN003

    Measured: Up to approximately 2 years

  11. Blood concentration of free toxins for JSKN003

    Measured: Up to approximately 2 years

  12. Serum concentration of KN026

    Measured: Up to approximately 2 years

  13. Serum concentration of Enlonstobart;

    Measured: Up to approximately 2 years

  14. Anti-drug antibodies (ADA) related to JSKN003

    Measured: Up to approximately 2 years

  15. Title: ADA related to KN026

    Measured: Up to approximately 2 years

  16. ADA related to Enlonstobart

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2025
  2. Study start15 Jun 2025 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
153 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06998771
Sponsor's protocol ID
JSKN003-003
Status last verified
May 2025
First submitted
12 May 2025
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JSKN003, KN026 and Capecitabine in people with HER2-positive Gastric Cancer, run by Shanghai JMT-Bio Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) of the first-line population (time frame: Frame: Up to approximately 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06998771.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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