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HER2-positive Gastric CancerPhase 2/3NCT07332533

A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer

A Phase 2/3 study testing KN026, Capecitabine and Enlonstobart 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 compare the efficacy and safety of KN026 combined chemotherapy with or without Enlonstobart versus Trastuzumab combined chemotherapy with or without Pembrolizumab as first-line treatment in HER2-positive unresectable locally advanced or metastatic 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?
KN026, Capecitabine and Enlonstobart
Could I receive a placebo?
No, everyone receives an active treatment
How many people
490 participants
Where
No sites listed yet
Study dates
30 Dec 2025to 31 Dec 2032
Phase
Phase 2/3
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.
  • Participants unresectable locally advanced or metastatic gastric cancer who had not received systemic treatment (participants who had progressed 6 months after prior neoadjuvant/adjuvant therapy could be enrolled).
  • Confirmed to be HER2 positive (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive) and PD-L1 status (participants of phase III should be confirmed by the pathology department of participating study center).
  • Phase II: 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. Phase III:Presence of at least 1 evaluable 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 participants 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 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 randomization.
  • Participants with brain metastasis or spinal cord compression at screening (except for completed local treatment and discontinued glucocorticoids for at least 4 weeks before 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 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 randomization. Or those who plan to undergo systematic or local tumor resection during the trial .
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  • 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 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 randomization. Participant who has recieved preventive infection treatment but has no clinical manifestations before 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) ; 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 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, Crohn's disease and other gastrointestinal diseases 28 days before randomization; Unable to swallow orally, or there are conditions that have been judged by researchers to seriously affect gastrointestinal absorption (such as malabsorption syndrome, etc.).
  • Has a history of severe cardiovascular disease.
  • History of any other malignant tumors within 5 years before randomization.
  • pleural effussion, peritoneal dropsy or pericardial effusion requiring drainage within 2 weeks before randomization.
  • Live vaccination within 28 days before randomization. Note: Seasonal influenza vaccine is a broadly inactivated vaccine and is allowed to be used;
  • Breastfeeding women.
  • Otherwise considered inappropriate for the study by the investigator.

About this study

Official title: A Phase II/III Study of KN026 Combined Chemotherapy With or Without Enlonstobart as First-line Treatment in HER2-positive Unresectable Locally Advanced or Metastatic Gastric Cancer.

This study is designed to compare the efficacy and safety of KN026 combined chemotherapy with or without Enlonstobart versus Trastuzumab combined chemotherapy with or without Pembrolizumab as first-line treatment in HER2-positive unresectable locally advanced or metastatic gastric cancer.

Being tested
KN026, Capecitabine, Enlonstobart, Oxaliplatin, Trastuzumab

What participants receive

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

  • KN026Drug

    In accordance with the protocol

  • 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.

  • CisplatinDrug

    Cisplatin is administered by intravenous infusion.

  • FluorouracilDrug

    Fluorouracil is administered by intravenous infusion.

Study groups in NCT07332533
Study groupRoleWhat they receive
Group A：Combination of KN026 and CAPOX/PF with or without enlonstobartExperimentalNot described
Receives: Drug: KN026; Drug: Capecitabine; Drug: Enlonstobart; Drug: Oxaliplatin; Drug: Cisplatin; Drug: Fluorouracil
Group B: Combination of trastuzumab, and CAPOX/PF with or without enlonstobartExperimentalNot described
Receives: Drug: Capecitabine; Drug: Enlonstobart; Drug: Oxaliplatin; Drug: Trastuzumab; Drug: Cisplatin; Drug: Fluorouracil
Experimental group: Combination of KN026 and CAPOX/PF with or without enlonstobartExperimentalNot described
Receives: Drug: KN026; Drug: Capecitabine; Drug: Enlonstobart; Drug: Oxaliplatin; Drug: Cisplatin; Drug: Fluorouracil
Control group：Combination of trastuzumab and CAPOX/PF with or without PembrolizumabExperimentalNot described
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Drug: Trastuzumab; Drug: Pembolizumab; Drug: Cisplatin; Drug: Fluorouracil

What is being measured

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

  1. Objective Response Rate (ORR) by investigator in Phase II

    Measured: Up to approximately 5 years

  2. Progression-Free Survival (PFS) by BIRC in Phase III

    Measured: Up to approximately 5 years

Secondary outcomes (1)

  1. Overall Survival (OS) in Phase III

    Measured: Up to approximately 5 years

Timeline

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

  1. First posted12 Jan 2026
  2. Study start30 Dec 2025 (estimated)
  3. Primary completion30 Jun 2032 (estimated)
  4. Study completion31 Dec 2032 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an open-label, randomized, controlled, multi-center Phase II/III clinical study.
Masking
None (open label)
Enrolment
490 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07332533
Sponsor's protocol ID
KN026-006
Status last verified
Dec 2025
First submitted
25 Dec 2025
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing KN026, Capecitabine and Enlonstobart 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 22 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 12 Jan 2026. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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) by investigator in Phase II (time frame: Up to approximately 5 years). The study lists 2 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 NCT07332533.

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 12 Jan 2026.

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