Metastatic Breast CancerPhase 2NCT04165993
Study of KN026 Monotherapy or Combination Therapy in Patients With Metastatic Breast Cancer
A Phase 2 study testing Concurrent chemotherapy and KN026, KN026 monotherapy and KN026 combination in people with Metastatic Breast Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Concurrent chemotherapy and KN026, KN026 monotherapy and KN026 combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2019to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject >= 18 years
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast 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
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 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
- History of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
- 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: Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer
This is an open-label, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.
Read the detailed description
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.The HER2- positive mBC subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg KN026 and docetaxol. The HER2 low expression and hormone-receptor positive mBC subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg KN026 monotherapy. The HER2 low expression and hormone-receptor negative/weak positive mBC subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg KN026 and 5 mg/kg KN046
- Conditions
- Metastatic Breast Cancer
- Being tested
- Concurrent chemotherapy and KN026, KN026 monotherapy, KN026 combination
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent chemotherapy and KN026Drug
Also called docetaxol
30 mg/kg Q3W KN026 75 mg/m2 docetaxol
KN026 monotherapyDrug
Also called KN026
30 mg/kg Q3W KN026
KN026 combinationDrug
Also called KN046
30 mg/kg Q3W KN026 5 mg/kg Q3W KN046
| Study group | Role | What they receive |
|---|---|---|
| Concurrent chemotherapy and KN026 | Experimental | KN026 combined with docetaxol Receives: Drug: Concurrent chemotherapy and KN026 |
| KN026 monotherapy | Experimental | KN026 monotherapy Receives: Drug: KN026 monotherapy |
| A combination treatment of KN026 and KN046 | Experimental | KN026 combined with KN046 Receives: Drug: KN026 combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment
Measured: Throughout the duration of the study; up to 2 years
Duration of response (DOR)
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
Measured: up to 2 years
Secondary outcomes (4)
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest
AEs, SAEs
Measured: Throughout the duration of the study
Progression free survival (PFS) rates
Progression free survival (PFS) rates
Measured: 6 months and 12 months
Overall survival (OS) rates
Overall survival (OS) rates
Measured: 6 months and 12 months
durable benefit rate (DBR)
durable benefit rate (DBR)
Measured: DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start31 Dec 2019
- Primary completion27 May 2021
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qingyuan Zhang, Professor, Principal investigator, The Second Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165993
- Sponsor's protocol ID
- KN026-201
- Status last verified
- Sep 2023
- First submitted
- 1 Nov 2019
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Efficacy and Safety Evaluation of KN026 Monotherapy or Combination Therapy in Patients With HER2 Expressing or Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04165993
- Acronym / sponsor ID
- KN026-201
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 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, three-cohort phase 2 study of KN026 in subjects with advanced breast Cancer.
Detailed description
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.The HER2- positive mBC subjects without systemic treatment will be enrolled in cohort 1 and received 30 mg/kg KN026 and docetaxol. The HER2 low expression and hormone-receptor positive mBC subjects failed standard chemotherapy and hormone therapy will be enrolled in cohort 2 and received 30 mg/kg KN026 monotherapy. The HER2 low expression and hormone-receptor negative/weak positive mBC subjects failed standard chemotherapy will be enrolled in cohort 3 and received 30 mg/kg KN026 and 5 mg/kg KN046
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Concurrent chemotherapy and KN026 | Experimental | Drug: Concurrent chemotherapy and KN026KN026 combined with docetaxol |
| KN026 monotherapy | Experimental | Drug: KN026 monotherapyKN026 monotherapy |
| A combination treatment of KN026 and KN046 | Experimental | Drug: KN026 combinationKN026 combined with KN046 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subject >= 18 years
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic breast 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 (7 listed)
- Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
- Accepted radiotherapy within 4 weeks before enrollment
- 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
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 |
|---|---|---|
| Concurrent chemotherapy and KN026Also: docetaxol30 mg/kg Q3W KN026 75 mg/m2 docetaxol | Drug | Concurrent chemotherapy and KN026 |
| KN026 monotherapyAlso: KN02630 mg/kg Q3W KN026 | Drug | KN026 monotherapy |
| KN026 combinationAlso: KN04630 mg/kg Q3W KN026 5 mg/kg Q3W KN046 | Drug | A combination treatment of KN026 and KN046 |
Primary outcome
Objective response rate (ORR)
Time frame: Throughout the duration of the study; up to 2 years
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment
Duration of response (DOR)
Time frame: up to 2 years
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment
4 secondary outcomes
Percentage of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest
Time frame: Throughout the duration of the study
Progression free survival (PFS) rates
Time frame: 6 months and 12 months
Overall survival (OS) rates
Time frame: 6 months and 12 months
durable benefit rate (DBR)
Time frame: DBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Qingyuan Zhang, Professor principal investigator
The Second Affiliated Hospital of Harbin Medical University
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 Concurrent chemotherapy and KN026, KN026 monotherapy and KN026 combination in people with Metastatic Breast 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 7 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
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) (time frame: Throughout the duration of the study; up to 2 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 21 Sep 2023.