HER2-positive Metastatic Breast CancerNCT04778982
Study of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Advanced Breast Cancer
An observational study of HER2-positive Metastatic Breast Cancer, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-positive Metastatic Breast Cancer
- What is being tested?
- KN026 combined with Palbociclib and Fulvestrant
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2022to 15 Mar 2023
- Phase
- Observational
- 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
Study population: diagnosing locally advanced unresectable or metastatic HER2-positive
Who may be able to join
- Male or female subject >= 18 years;
- Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive;
- Adequate organ function assessed within 7 days prior to first trial treatment
- ECOG score 0 or 1;
- Left ventricular ejection fraction (LVEF) ≥ 50% at baseline;
- Life expectancy >3 months
Who cannot join
- Untreated active CNS metastasis or leptomeningeal metastasis;
- Uncontrolled tumor-related pain;
- Has received other anti-tumor treatment or an investigational drug within 28 days or within 5 times of half-life (whichever is shorter, and no less than 2 weeks) prior to the first trial treatment;
- Major surgery for any reason within 28 days;
- Curative radiation within 3 months of the first dose of trial treatment;
- History of uncontrolled intercurrent illness;
- Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Locally Advanced HER2-positive Breast Cancer
This is an open-label, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+ palbociclib 100/125 mg/day orally+/-Fulvestrant 500 mg IM until progressive disease, unacceptable toxicity or death.
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.
- Conditions
- HER2-positive Metastatic Breast Cancer
- Being tested
- KN026 combined with Palbociclib and Fulvestrant
- Keywords
- KN026, palbociclib, HER2-positive MBC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN026 combined with Palbociclib and FulvestrantDrug
Also called combination
HR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg
| Study group | Role | What they receive |
|---|---|---|
| dose-escalation Phase | KN026 20 mg/kg + palbociclib125 mg/day+Fulvestrant 500 mg (Patients with HR+/HER2-positive MBC ) | |
| parallel-group expansion Phase | KN026 20 mg/kg + palbociclib +Fulvestrant 500 mg(Patients with HR+/HER2-positive MBC ) Receives: Drug: KN026 combined with Palbociclib and Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
The proportion of patients experiencing dose limiting toxicities
Measured: up to 24 weeks
Objective response rate (ORR)
ORR as assessed by the investigator according to RECIST 1.1
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Duration of response (DOR)
clinical response time (DOR) as determined by investigators based on RECIST 1.1 criteria
Measured: through study completion, an average of 1 year
Progression free survival (PFS) rates
Progression free survival (PFS) rates
Measured: 6 months and 12 months
Overall survival (OS)
Overall survival (OS) rates
Measured: 6 months and 12 months
Clinical benefit rate (CBR)
Clinical benefit rate
Measured: CBR 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 posted3 Mar 2021
- Study start25 May 2022
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Why it stopped: Difficulty in completing enrollment within the planned time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 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
- NCT04778982
- Sponsor's protocol ID
- KN026-205
- Status last verified
- Jul 2023
- First submitted
- 26 Feb 2021
- Last updated
- 17 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With Palbociclib and Fulvestrant in Patients With Locally Advanced HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT04778982
- Acronym / sponsor ID
- KN026-205
- Conditions
- HER2-positive Metastatic Breast Cancer
- Keywords
- KN026, palbociclib, HER2-positive MBC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty in completing enrollment within the planned time
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 May 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 3 Mar 2021 (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, multicenter, dose-escalation and parallel-group expansion Phase II clinical trial to evaluate the efficacy, safety and tolerability of KN026 in combination with palbociclib and fulvestrant in women or male with HER2-positive metastatic breast cancer .The subjects will receive 20 mg/kg IV Q2W+ palbociclib 100/125 mg/day orally+/-Fulvestrant 500 mg IM until progressive disease, unacceptable toxicity or death.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose-escalation Phase | – | –KN026 20 mg/kg + palbociclib125 mg/day+Fulvestrant 500 mg (Patients with HR+/HER2-positive MBC ) |
| parallel-group expansion Phase | – | Drug: KN026 combined with Palbociclib and FulvestrantKN026 20 mg/kg + palbociclib +Fulvestrant 500 mg(Patients with HR+/HER2-positive MBC ) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diagnosing locally advanced unresectable or metastatic HER2-positive
Key inclusion criteria (6 listed)
- Male or female subject >= 18 years;
- Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive;
- Adequate organ function assessed within 7 days prior to first trial treatment
- ECOG score 0 or 1;
- Left ventricular ejection fraction (LVEF) ≥ 50% at baseline;
Key exclusion criteria (7 listed)
- Untreated active CNS metastasis or leptomeningeal metastasis;
- Uncontrolled tumor-related pain;
- Has received other anti-tumor treatment or an investigational drug within 28 days or within 5 times of half-life (whichever is shorter, and no less than 2 weeks) prior to the first trial treatment;
- Major surgery for any reason within 28 days;
- Curative radiation within 3 months of the first dose of trial treatment;
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 combined with Palbociclib and FulvestrantAlso: combinationHR+/HER2-positive MBC will be treated by KN026 20 mg/kg+Palbociclib+fulvestrant 500 mg | Drug | parallel-group expansion Phase |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: up to 24 weeks
The proportion of patients experiencing dose limiting toxicities
Objective response rate (ORR)
Time frame: through study completion, an average of 1 year
ORR as assessed by the investigator according to RECIST 1.1
4 secondary outcomes
Duration of response (DOR)
Time frame: through study completion, an average of 1 year
Progression free survival (PFS) rates
Time frame: 6 months and 12 months
Overall survival (OS)
Time frame: 6 months and 12 months
Clinical benefit rate (CBR)
Time frame: CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks
Results and safety
The study was stopped early (reason given: Difficulty in completing enrollment within the planned time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
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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?
An observational study of HER2-positive 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 6 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: stopped early, as of the sponsor's last update on 17 Jul 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.
Are results available for this study?
The study was stopped early (reason given: Difficulty in completing enrollment within the planned time). 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?
Dose limiting toxicity (DLT) (time frame: up to 24 weeks). 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 17 Jul 2023.