Breast CancerPhase 1NCT03619681
Trial of KN026 in Patients With HER2-positive Advanced Malignant Breast Cancer and Gastric Cancer
A Phase 1 study testing KN026 in people with Breast Cancer and Gastric Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Gastric Cancer
- What is being tested?
- KN026
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2018to 26 Aug 2022
- Phase
- Phase 1
- 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
- Male or female subject >= 18 years and =<75 years.
- Histologically or cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
- ECOG score 0 or 1.
- Life expectancy >3 months.
- According to the definition of RECIST1.1, the patient has at least one measurable lesion.
- Adequate organ function prior to start treatment with KN026.
- Able to understand, voluntarily participate and willing to sign the ICF.
- Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.
Who cannot join
- Accepted any other anti-tumor drug therapies within 4 weeks before fist dose.
- Accepted radiotherapy within 4 weeks before enrollment(Subjects are eligible, which accepted palliative therapies within 2 weeks before the first dose of KN026 for osseous metastatic and all the AEs recovered).
- An anthracyclines antibiotic treatment, such as doxorubicin (Adriamycin) was received exceeding 300 mg/m² within 90 days before first KN026 dosing, 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.
- Has not recovered (ie, >Grade 1) from AEs except alopecia and anemia.
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- History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Open Lable, Dose Escalation Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Preliminary Efficacy of KN026 Monotherapy in Patients With HER2-positive Advanced Malignant Breast and Gastric Cancer
This is a first-in-human (FIH), open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 5 proposed dose levels which are 5, 10, 15, 20 and 30 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached. Dose expansion will carried out in 20 mg/kg Q2W and 30 mg/kg Q3W.
- Conditions
- Breast Cancer, Gastric Cancer
- Being tested
- KN026
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN026Drug
Patient will be intravenously administrated with one dose of KN026. dosing interval may be adjusted during the study based on emerging data from this trial and/or from other trial.
| Study group | Role | What they receive |
|---|---|---|
| KN026 | Experimental | Not described Receives: Drug: KN026 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients experiencing dose limiting toxicities.
Measured: From screening to up to 28 days
Secondary outcomes (11)
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest.
Measured: From screening to up to 112 days
Percentage of participants who experience laboratory abnormalities and/or adverse events as defined by CTCAE that are related to treatment
Measured: From screening to up to 112 days
Maximum observed serum concentration (Cmax) of KN026.
Measured: Throughout the duration of the study; up to 84 days
Time of Maximum observed serum concentration (Tmax) of KN026.
Measured: Throughout the duration of the study; up to 84 days
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) for KN026.
Measured: Throughout the duration of the study; up to 84 days
Serum Half-life (T-HALF) of KN026.
Measured: Throughout the duration of the study; up to 84 days.
Serum clearance (CL) of KN026.
Measured: Throughout the duration of the study; up to 84 days
Volume of distribution at steady state (VSS) of KN026.
Measured: Throughout the duration of the study; up to 84 days
Frequency and titer of anti-KN026 antibody.
Measured: Throughout the duration of the study; up to 2 years.
The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria.
Measured: Throughout the duration of the study; up to 2 years.
Progression free survival according to RECIST 1.1 criteria.
Measured: Throughout the duration of the study; up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start17 Sep 2018
- Primary completion30 Jun 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 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
- NCT03619681
- Sponsor's protocol ID
- KN026-CHN-001
- Status last verified
- Nov 2023
- First submitted
- 3 Aug 2018
- 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
- A Single Arm, Open Lable, Dose Escalation Phase I Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Preliminary Efficacy of KN026 Monotherapy in Patients With HER2-positive Advanced Malignant Breast and Gastric Cancer
- ClinicalTrials.gov ID
- NCT03619681
- Acronym / sponsor ID
- KN026-CHN-001
- Conditions
- Breast Cancer, Gastric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 8 Aug 2018 (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 first-in-human (FIH), open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation. There are 5 proposed dose levels which are 5, 10, 15, 20 and 30 mg/kg, but dosing interval may be adjusted during the study (such as QW, OR Q2W, OR Q3W) based on emerging data from this trial and/or from phase 1 trial of KN026 in other country. Dose escalation will continue until the maximum tolerated dose (MTD) is reached or if MTD is not found, dose escalation will continue until the MAD of 20 mg / kg is reached. Dose expansion will carried out in 20 mg/kg Q2W and 30 mg/kg Q3W.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN026 | Experimental | Drug: KN026 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subject >= 18 years and =<75 years.
- Histologically or cytologically confirmed, locally advanced unresectable or metastatic breast cancer or gastric cancer.
- ECOG score 0 or 1.
- Life expectancy >3 months.
- According to the definition of RECIST1.1, the patient has at least one measurable lesion.
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(Subjects are eligible, which accepted palliative therapies within 2 weeks before the first dose of KN026 for osseous metastatic and all the AEs recovered).
- An anthracyclines antibiotic treatment, such as doxorubicin (Adriamycin) was received exceeding 300 mg/m² within 90 days before first KN026 dosing, 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 |
|---|---|---|
| KN026Patient will be intravenously administrated with one dose of KN026. dosing interval may be adjusted during the study based on emerging data from this trial and/or from other trial. | Drug | KN026 |
Primary outcome
The proportion of patients experiencing dose limiting toxicities.
Time frame: From screening to up to 28 days
11 secondary outcomes
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest.
Time frame: From screening to up to 112 days
Percentage of participants who experience laboratory abnormalities and/or adverse events as defined by CTCAE that are related to treatment
Time frame: From screening to up to 112 days
Maximum observed serum concentration (Cmax) of KN026.
Time frame: Throughout the duration of the study; up to 84 days
Time of Maximum observed serum concentration (Tmax) of KN026.
Time frame: Throughout the duration of the study; up to 84 days
Adjusted geometric means of area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUC(0-T)) for KN026.
Time frame: Throughout the duration of the study; up to 84 days
Serum Half-life (T-HALF) of KN026.
Time frame: Throughout the duration of the study; up to 84 days.
Serum clearance (CL) of KN026.
Time frame: Throughout the duration of the study; up to 84 days
Volume of distribution at steady state (VSS) of KN026.
Time frame: Throughout the duration of the study; up to 84 days
Frequency and titer of anti-KN026 antibody.
Time frame: Throughout the duration of the study; up to 2 years.
The proportion of patients with an objective response (partial response or complete response) as defined by RECIST 1.1 criteria.
Time frame: Throughout the duration of the study; up to 2 years.
Progression free survival according to RECIST 1.1 criteria.
Time frame: Throughout the duration of the study; up to 2 years.
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 1 study testing KN026 in people with Breast Cancer and Gastric 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 8 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The proportion of patients experiencing dose limiting toxicities. (time frame: From screening to up to 28 days). 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; AzTrials last refreshed its copy on 7 Nov 2026.