HER2-positive Locally Advanced Resectable Gastric CancerPhase 2NCT06023758
Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC
A Phase 2 study testing KN026, KN046 and XELOX in people with HER2-positive Locally Advanced Resectable Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-positive Locally Advanced Resectable Gastric Cancer
- What is being tested?
- KN026, KN046 and XELOX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2023to 31 Dec 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject can understand the informed consent, voluntarily participate and sign the informed consent ;
- Subjects are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent；
- Histologically or cytologically confirmed, locally advanced HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma.
- ECOG score 0 or 1;
- Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO (preferred) or MUGA;
- Liver function met the following criteria within 7 days prior to initial administration:
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- Total bilirubin ≤1.0x ULN (Gilbert's syndrome, or total bilirubin ≤1.5x ULN in liver metastases); Aminotransferase (ALT/AST) ≤1.5x ULN (liver metastatic subjects ≤3xULN); -Renal function within 7 days prior to initial administration: serum creatinine ≤1.5x ULN and serum creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation);
- Bone marrow function met the following criteria within 7 days prior to initial administration: Hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5 x 109/L; Platelet count ≥100x 109/L; INR or PT≤1.5x ULN, and aPTT≤ 1.5x ULN;
- Life expectancy >3 months;
- The subjects are able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol
Who cannot join
- Existence of other active malignant tumors within 5 years or at the same time. Plan to perform or have undergone an organ or bone marrow transplant. Myocardial infarction and poorly controlled arrhythmias occurred within 6 months prior to the first dose.
- Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram shows: LVEF (left ventricular ejection fraction) < 50%.
- Human immunodeficiency virus (HIV) infection.
- Patients with active tuberculosis.
- Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
- Patients who have previously received other antibody/drug treatments for immune checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.
- Have diseases that may increase the risk of participating in the study and using the study medications, or other severe, acute, and chronic diseases and therefore are judged by the investigator to be unsuitable for clinical studies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, doctorshenlin@sina.cn
Shen Lin, professor
About this study
Official title: A Multicenter II Study to Compare KN026 and KN046 Versus Oxaliplatin, Capecitabine Combined KN026 and KN046 in Patients With HER2-positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.
This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma.
Read the detailed description
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, resulting in dual HER2 signaling blockade.KN046 is a PD-L1 - CTLA-4 bispecific antibody. The trial consists of two groups. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W in Group 1. If the statistical hypothesis is not met in Group 1, patients will be enrolled in Group 2. Patients in group 2 will receive KN026+KN046+XELOX.
- Being tested
- KN026, KN046, XELOX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN026Drug
KN026：30 mg/kg Q3W
KN046Drug
KN046：5 mg/kg Q3W
XELOXDrug
Oxaliplatin 130mg/m2 d1，Capecitabine 1000mg/m2 d1-14，Q3W
| Study group | Role | What they receive |
|---|---|---|
| KN026 combined with KN046 | Experimental | KN026 combined with KN046 Receives: Drug: KN026; Drug: KN046 |
| KN026，KN046 and XELOX | Experimental | KN026，KN046 and XELOX Receives: Drug: KN026; Drug: KN046; Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)
Measured: up to 2 years
Secondary outcomes (3)
Event-free survival (EFS)
Event-free survival (assessed by the investigator per RECIST v1.1 criteria)
Measured: from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years
Disease-free survival (DFS)
Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)
Measured: from the start of surgery to disease recurrence or death (for any reason)，assessed up to 3 years
overall survival (OS)
overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start22 Sep 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Locally Advanced Resectable Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023758
- Sponsor's protocol ID
- KHER2-001
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter II Study to Compare KN026 and KN046 Versus Oxaliplatin, Capecitabine Combined KN026 and KN046 in Patients With HER2-positive Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT06023758
- Acronym / sponsor ID
- KHER2-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter II study to compare KN026 and KN046 versus Oxaliplatin, Capecitabine combined KN026 and KN046 in patients with HER2-positive locally advanced resectable gastric cancer or gastroesophageal junction adenocarcinoma.
Detailed description
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, resulting in dual HER2 signaling blockade.KN046 is a PD-L1 - CTLA-4 bispecific antibody. The trial consists of two groups. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W in Group 1. If the statistical hypothesis is not met in Group 1, patients will be enrolled in Group 2. Patients in group 2 will receive KN026+KN046+XELOX.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KN026 combined with KN046 | Experimental | Drug: KN026, Drug: KN046KN026 combined with KN046 |
| KN026，KN046 and XELOX | Experimental | Drug: KN026, Drug: KN046, Drug: XELOXKN026，KN046 and XELOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject can understand the informed consent, voluntarily participate and sign the informed consent ;
- Subjects are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent；
- Histologically or cytologically confirmed, locally advanced HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma.
- ECOG score 0 or 1;
- Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO (preferred) or MUGA;
Key exclusion criteria (7 listed)
- Existence of other active malignant tumors within 5 years or at the same time. Plan to perform or have undergone an organ or bone marrow transplant. Myocardial infarction and poorly controlled arrhythmias occurred within 6 months prior to the first dose.
- Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram shows: LVEF (left ventricular ejection fraction) < 50%.
- Human immunodeficiency virus (HIV) infection.
- Patients with active tuberculosis.
- Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KN026KN026：30 mg/kg Q3W | Drug | KN026 combined with KN046, KN026，KN046 and XELOX |
| KN046KN046：5 mg/kg Q3W | Drug | KN026 combined with KN046, KN026，KN046 and XELOX |
| XELOXOxaliplatin 130mg/m2 d1，Capecitabine 1000mg/m2 d1-14，Q3W | Drug | KN026，KN046 and XELOX |
Primary outcome
pCR rate
Time frame: up to 2 years
Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)
3 secondary outcomes
Event-free survival (EFS)
Time frame: from enrollment until firstly confirmed and recorded disease progression or death，assessed up to 3 years
Disease-free survival (DFS)
Time frame: from the start of surgery to disease recurrence or death (for any reason)，assessed up to 3 years
overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KN026, KN046 and XELOX in people with HER2-positive Locally Advanced Resectable Gastric Cancer, run by Peking University at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2024.