HER2-positive Breast CancerPhase 2NCT04034823
KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
A Phase 2 study testing KN035, Trastuzumab and Docetaxel in people with HER2-positive Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Trial summary
This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- KN035, Trastuzumab and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Jan 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Female subjects with age 18 to 70 (inclusive) years at the time of consent
- LVEF ≥50% at baseline
- ECOG performance status of 0-1
- Have not received 1L treatment for recurrent or metastatic breast cancer
- Adequate organ function
Who cannot join
- History of exposure to the cumulative doses of doxorubicin > 400 mg / m2 or equivalent
- History of autoimmune diseases
- Active brain metastasis
- Concurrent diseases that compromise patient's safety
About this study
Official title: KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
This is an open-label, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- KN035, Trastuzumab, Docetaxel
- Keywords
- HER2-positive breast cancer, PD-L1 immune checkpoint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN035Biological
KN035 5 mg/kg s.c. Q3W
TrastuzumabBiological
8 mg/kg IV loading followed by 6 mg/kg Q3W IV
DocetaxelDrug
100 mg/m2 Q3W IV
| Study group | Role | What they receive |
|---|---|---|
| KN035 in combination with trastuzumab and docetaxel | Experimental | Not described Receives: Biological: KN035; Biological: Trastuzumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response
To estimate the overall response rate (CR + PR) of KN035 in combination with trastuzumab and docetaxel in patients with recurrent or metastatic HER2-positive breast cancer.
- Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator
Measured: 12 months
Secondary outcomes (1)
Adverse events
To characterize the toxicity of KN035 in combination with trastuzumab and docetaxel as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JZhao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034823
- Sponsor's protocol ID
- KN035-TH-HER2
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KN035, a Single Domain PD-L1 Subcutanuous Injection Antibody, in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT04034823
- Acronym / sponsor ID
- KN035-TH-HER2
- Conditions
- HER2-positive Breast Cancer
- Keywords
- HER2-positive breast cancer, PD-L1 immune checkpoint
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 26 Jul 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, single arm phase II trial to evaluate the efficacy, safety and tolerability of KN035 in combination with trastuzumab and docetaxel. Eligible patient will be enrolled and receive protocol defined therapies until progressive disease, unacceptable toxicity or withdrawal of informed consent. Tumor assessment will be performed according to RECIST 1.1 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN035 in combination with trastuzumab and docetaxel | Experimental | Biological: KN035, Biological: Trastuzumab, Drug: Docetaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent
- Female subjects with age 18 to 70 (inclusive) years at the time of consent
- LVEF ≥50% at baseline
- ECOG performance status of 0-1
- Have not received 1L treatment for recurrent or metastatic breast cancer
Key exclusion criteria (4 listed)
- History of exposure to the cumulative doses of doxorubicin > 400 mg / m2 or equivalent
- History of autoimmune diseases
- Active brain metastasis
- Concurrent diseases that compromise patient's safety
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 |
|---|---|---|
| KN035KN035 5 mg/kg s.c. Q3W | Biological | KN035 in combination with trastuzumab and docetaxel |
| Trastuzumab8 mg/kg IV loading followed by 6 mg/kg Q3W IV | Biological | KN035 in combination with trastuzumab and docetaxel |
| Docetaxel100 mg/m2 Q3W IV | Drug | KN035 in combination with trastuzumab and docetaxel |
Primary outcome
Objective response
Time frame: 12 months
To estimate the overall response rate (CR + PR) of KN035 in combination with trastuzumab and docetaxel in patients with recurrent or metastatic HER2-positive breast cancer. • Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator
1 secondary outcome
Adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KN035, Trastuzumab and Docetaxel in people with HER2-positive Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
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 4 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: 12 months). 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 26 Jul 2019.