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New treatment option for Stomach Cancer
Official title KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy
ClinicalTrials.gov ID: NCT05427383
What this study is testing
What is KN026/Placbo Injection?
KN026/Placbo Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stomach cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years;
- Histologically or cytology-confirmed HER2-positive locally advanced, recurrent, or metastatic gastric cancer (including adenocarcinoma of the...
- Failure of at least first-line standard therapy (trastuzumab plus chemotherapy); Note: Neoadjuvant/adjuvant therapy previously administered with a...
- Stage 1 : At least one measurable lesion at baseline according to RECIST 1.1; Stage 2: At least one evaluable lesion at baseline according to RECIST...
- ECOG Performance Status of 0 to 1.
You likely can't join if
- people with untreated active brain metastases; people will be admitted if their brain metastases have been treated and the metastases are stable...
- Other investigational medications received within 4 weeks prior to the first study treatment, based on the time of the last trial dose;
- Antineoplastic therapy such as chemotherapy, small molecule inhibitors, immunotherapy (such as interleukin, interferon, or thymosin) within 4 weeks...
- people recieved major surgery (e.g., transabdominal, transthoracic, etc.) within 28 days prior to the first study treatment; does not include minor...
- Previous cumulative doses of doxorubicin exceeding 320 mg/m\^2, or equivalent conversion of other anthracyclines (anthracycline equivalent: 1 mg...
- Previous use of anti-HER2 therapy other than trastuzumab (eg, ADC, dual-antibody, small molecule targeted therapy, etc.).
See the full eligibility criteria
Who can join
- Age ≥18 years;
- Histologically or cytology-confirmed HER2-positive locally advanced, recurrent, or metastatic gastric cancer (including adenocarcinoma of the gastro-esophageal junction); HER2 positive is defined as IHC 3+, or IHC 2+...
- Failure of at least first-line standard therapy (trastuzumab plus chemotherapy); Note: Neoadjuvant/adjuvant therapy previously administered with a trastuzumab-containing regimen can be considered first-line therapy if...
- Stage 1 : At least one measurable lesion at baseline according to RECIST 1.1; Stage 2: At least one evaluable lesion at baseline according to RECIST 1.1; the area must not have received previous radiotherapy, or there...
- ECOG Performance Status of 0 to 1.
- Life expectancy ≥ 3 months.
- 7\. The function of major organs must meet the following criteria : Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil (ANC) ≥ 1.5×10\^9/L; Platelet (PLT) ≥ 90×10\^9/L; (No whole blood or component blood transfusion in the...
- Left ventricular ejection fraction (LVEF) ≥ 50% or lower limit of normal (LLN) in local sites, measured by echocardiography (ECHO), cardiac radionuclide scanning (MUGA) only in the absence of ECHO, with consistency at...
- people agreed to use effective contraception during the study and for 6 months after the last dose (women of childbearing age must confirm a negative serum pregnancy test within 7 days prior to enrollment);
- Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period and through at least 6 months after the last dose of study drug. (Women of childbearing age...
- people are able and willing to comply with the study protocol.
What rules you out
- people with untreated active brain metastases; people will be admitted if their brain metastases have been treated and the metastases are stable (brain imaging at least 4 weeks prior to the first dose showed stable...
- Other investigational medications received within 4 weeks prior to the first study treatment, based on the time of the last trial dose;
- Antineoplastic therapy such as chemotherapy, small molecule inhibitors, immunotherapy (such as interleukin, interferon, or thymosin) within 4 weeks or 5 half-lives (whichever is shorter but at least 2 weeks) prior to...
- people recieved major surgery (e.g., transabdominal, transthoracic, etc.) within 28 days prior to the first study treatment; does not include minor procedures such as diagnostic puncture or infusion device...
- Previous cumulative doses of doxorubicin exceeding 320 mg/m\^2, or equivalent conversion of other anthracyclines (anthracycline equivalent: 1 mg doxorubicin = 2 mg epirubicin = 2 mg pyrrubicin = 2 mg daunorubicin = 0.5...
- Previous use of anti-HER2 therapy other than trastuzumab (eg, ADC, dual-antibody, small molecule targeted therapy, etc.).
- Pregnant or lactating women; or intend pregnancy during the trial or within 6 months of the end of the trial;
- people with a history of life-threatening allergies or known allergies to protein drugs or recombinant proteins or to one of excipients in KN026 drugs (histidine, glacial acetic acid, sucrose, and polysorbate 20) who...
- Adverse events have not returned to CTCAE 5.0 grade ≤ grade 1 or baseline from previous anti-tumor treatments , except for alopecia, skin pigmentation and those assessed by the investigators without potential safety...
- Uncontrollable diarrhoea (≥grade 2 that does not improve within 48 hours of medication);
- people with the following history of cardiovascular disease:
- people with uncontrolled hypertension (defined as sustained systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg despite antihypertensive medication);
- Any history of symptomatic congestive heart failure (NYHA classification II-IV); the absolute value of LVEF decreased by ≥10% and absolute value \< 50% , or the absolute value of LVEF decreased by ≥15% , during or after...
- History of myocardial infarction within 6 months before treatment of the first dose;
- people with angina and unstable angina within three months prior to treatment in the first dose;
- Severe arrhythmias and conduction abnormalities requiring antiarrhythmic therapy other than β-blockers or digoxin (except atrial fibrillation and paroxysmal supraventricular tachycardia) within 6 months prior to...
- QTcF \> 450 ms (male); QTcF \> 470ms (Female);
- Other heart diseases that the investigators consider clinically significant;
- Poorly controlled systemic diseases judged by investigators, including diabetes;
- Severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy (eg, anti-infective drugs have been used for more than 1 week before the trial and will continue to be used)...
- Received systemic corticosteroids (\> 10 mg/day of prednisone, or equivalent amounts of other corticosteroids) within 2 weeks prior to treatment in the first dose; inhaled steroids or topical cortisol is permitted...
- History of noninfectious interstitial lung disease, or interstitial pneumonia requiring hormonal therapy;
- History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;
- Active HBV [HBsAg or HBcAb-positive with HBV DNA \> 500 IU/mL (or 2500 copies/mL)] or HCV infection [subjetcs with polymerase chain reaction (PCR)-negative HCV ribonucleic acid (RNA) can participate in this study] or...
- History of any other malignant tumors within five years prior to the first dose, except cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-muscle-invasive bladder cancer, localized low-risk prostate...
- Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) requiring drainage or diuretic therapy, within 2 weeks prior to the first dose of treatment; Diuretics for other reasons are permitted;
- Known mismatch repair deficient (dMMR) or highly unstable microsatellite (MSI-H) without previous PD-1/PD-L1 monoclonal antibody therapy;
- Unintentional weight loss of ≥5% within 1 month prior to the first dose, despite peripheral or central venous nutritional support;
- Inability to tolerate or refuse chemotherapy required by the protocol;
- The investigator considered the subject to be unsuitable for participation in this clinical study due to the presence of any clinical or laboratory abnormalities or history of systemic disease or other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.