Gastric/Gastroesophageal Junction CancerPhase 2NCT03925974
KN026 in Patients With HER2 Expressing Gastric/Gastroesophageal Junction Cancer
A Phase 2 study testing KN026 10 mg/kg QW, KN026 20 mg/kg Q2W and KN026 30 mg/kg Q3W in people with Gastric/Gastroesophageal Junction Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric/Gastroesophageal Junction Cancer
- What is being tested?
- KN026 10 mg/kg QW, KN026 20 mg/kg Q2W and KN026 30 mg/kg Q3W
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2019to 31 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Signed inform consent form(ICF)
- Age ≥ 18 years and ≤ 75 years, male or female
- Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ \& ISH+ HER2 expressing: IHC2+ \& ISH- or IHC 1+ \& ISH+
- Received at least one prior standard therapy
- At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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- Adequate organ function
- LVEF≥ 50% (ECHO)
- Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
- Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures
Who cannot join
- Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
- Accepted radiotherapy within 4 weeks before enrollment
- An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
- Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
- Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
- History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
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- Severe chronic and active infection, need to system antibiosis/antiviral treatment
- Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
- Even with peripheral or central venous nutritional support, unintentional weight loss ≥5% within 1 month before the first medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Evaluating Efficacy, Safety and Tolerance of KN026 in HER2 Expressing Advanced Gastric/Gastroesophageal Junction Cancer
This is an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.
Read the detailed description
The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.
- Conditions
- Gastric/Gastroesophageal Junction Cancer
- Being tested
- KN026 10 mg/kg QW, KN026 20 mg/kg Q2W, KN026 30 mg/kg Q3W
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN026 10 mg/kg QWDrug
10 mg/kg QW as safety run-in dosage
KN026 20 mg/kg Q2WDrug
20 mg/kg Q2W as target dosage
KN026 30 mg/kg Q3WDrug
30 mg/kg Q3W as another target dosage
| Study group | Role | What they receive |
|---|---|---|
| HER2 overexpression | Experimental | HER2 IHC 3+ or IHC2+ and ISH+ Receives: Drug: KN026 10 mg/kg QW; Drug: KN026 20 mg/kg Q2W; Drug: KN026 30 mg/kg Q3W |
| HER2 expression | Experimental | HER2 IHC 2+ISH- or IHC 1+ and ISH+ Receives: Drug: KN026 10 mg/kg QW; Drug: KN026 20 mg/kg Q2W; Drug: KN026 30 mg/kg Q3W |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria
Measured: 1 years
DOR
clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start17 Jun 2019
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric/Gastroesophageal Junction CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Alphamab Biopharmaceuticals Co., LtdThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925974
- Sponsor's protocol ID
- KN026-202
- Status last verified
- Nov 2023
- First submitted
- 22 Apr 2019
- Last updated
- 12 Mar 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Evaluating Efficacy, Safety and Tolerance of KN026 in HER2 Expressing Advanced Gastric/Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT03925974
- Acronym / sponsor ID
- KN026-202
- Conditions
- Gastric/Gastroesophageal Junction Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 24 Apr 2019 (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 an open-label, phase 2 study of KN026 in subjects with HER2 expressing gastric/gastroesophageal junction cancer to evaluate efficacy and safety. The subjects will receive KN026 10 mg/kg QW or 20 mg/kg Q2W or 30mg/kg Q3W until progressive disease, unacceptable toxicity or death.
Detailed description
The study consists of two arms as HER2 overexpression arm and HER2 expression arm and both arms will receive KN026 treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HER2 overexpression | Experimental | Drug: KN026 10 mg/kg QW, Drug: KN026 20 mg/kg Q2W, Drug: KN026 30 mg/kg Q3WHER2 IHC 3+ or IHC2+ and ISH+ |
| HER2 expression | Experimental | Drug: KN026 10 mg/kg QW, Drug: KN026 20 mg/kg Q2W, Drug: KN026 30 mg/kg Q3WHER2 IHC 2+ISH- or IHC 1+ and ISH+ |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed inform consent form(ICF)
- Age ≥ 18 years and ≤ 75 years, male or female
- Histologically or cytologically documented advanced gastric/gastroesophageal junction cancer HER2 overexpressing: IHC 3+ or IHC 2+ \& ISH+ HER2 expressing: IHC2+ \& ISH- or IHC 1+ \& ISH+
- Received at least one prior standard therapy
- At least one evaluable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
Key exclusion criteria (9 listed)
- Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
- Accepted radiotherapy within 4 weeks before enrollment
- An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
- Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
- Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
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 |
|---|---|---|
| KN026 10 mg/kg QW10 mg/kg QW as safety run-in dosage | Drug | HER2 expression, HER2 overexpression |
| KN026 20 mg/kg Q2W20 mg/kg Q2W as target dosage | Drug | HER2 expression, HER2 overexpression |
| KN026 30 mg/kg Q3W30 mg/kg Q3W as another target dosage | Drug | HER2 expression, HER2 overexpression |
Primary outcome
ORR
Time frame: 1 years
clinical response rate (ORR) as determined by investigators based on RECIST 1.1 criteria
DOR
Time frame: 1 years
clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 10 mg/kg QW, KN026 20 mg/kg Q2W and KN026 30 mg/kg Q3W in people with Gastric/Gastroesophageal Junction Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd 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 9 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: finished, as of the sponsor's last update on 12 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ORR (time frame: 1 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?
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 Mar 2024.