First-line Treatment of HER2-positive Recurrent or Metastatic Breast CancerPhase 3NCT05838066
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
A Phase 3 study testing Recombinant Humanized Bispecific antibody against HER2，KN026, HB1801 and Pertuzumab in people with First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer, run by Shanghai JMT-Bio Inc. at 1 site in China.
Trial summary
This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
- What is being tested?
- Recombinant Humanized Bispecific antibody against HER2，KN026, HB1801 and Pertuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2023to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Voluntarily enrolled in this study and signed an informed consent form (ICF).
- Age ≥ 18 years.
- Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
- Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
- No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1.
- Presence of lesion (RECIST 1.1).
- Adequate organ and bone marrow function
Who cannot join
- Ineligible for any of the agents on the study
- Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.
- Pregnant or lactating women.
- Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Clinical Trials Information Group
Beijing, chaoyang
Clinical Trials Information Group Officer, +86-0311-69085587, ctr-contact@mail.ecspc.com
Clinical Trials Information Group Officer, +86-0311-69085587
About this study
Official title: A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).
Read the detailed description
The purpose of this study is to assess the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer. This study will establish an independent data monitoring committee (IDMC) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. During the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. In addition, the IDMC plans to conduct one interim analysis of efficacy during the study period.
The primary study hypotheses are that the combination of KN026 combined with HB1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: Progression-free Survival (PFS) as assessed by the BIRC per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Being tested
- Recombinant Humanized Bispecific antibody against HER2，KN026, HB1801, Pertuzumab, Trastuzumab, Docetaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Humanized Bispecific antibody against HER2，KN026Drug
IV infusion
HB1801Drug
IV infusion
PertuzumabDrug
840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion
TrastuzumabDrug
8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion
DocetaxelDrug
75 mg/m^2, D1 Q3W, IV infusion
| Study group | Role | What they receive |
|---|---|---|
| KN026+HB1801 | Experimental | Subjects will receive an intravenous (IV) infusion of KN026 plus HB1801. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurrs first. Receives: Drug: Recombinant Humanized Bispecific antibody against HER2，KN026; Drug: HB1801 |
| Trastuzumab + Pertuzumab + Docetaxel | Active comparator | On Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg/kg loading dose followed by 6 mg/kg per cycle, IV, D1, Q3W and docetaxel 75 mg/m^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first. Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1).
Measured: Up to approximately 4 years
Secondary outcomes (9)
PFS (investigator assessment, RECIST1.1)
Measured: Up to approximately 4 years
Overall survival (OS)
Measured: Up to approximately 4 years
Objective response rate (ORR)
Measured: Up to approximately 4 years
Disease control rate (DCR)
Measured: Up to approximately 4 years
Duration of response (DoR)
Measured: Up to approximately 4 years
Frequency and severity of TEAE and SAE
Measured: Up to approximately 4 years
Concentration of KN026 in serum
Measured: Up to approximately 4 years
Concentration of HB1801 in serum
Measured: Up to approximately 4 years
Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start23 Jul 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First-line Treatment of HER2-positive Recurrent or Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838066
- Sponsor's protocol ID
- KN026-003
- Status last verified
- May 2025
- First submitted
- 20 Apr 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Li H, Xu F, Wu T, Tong Z, Cui J, Wang X, Song Z, Sun T, Li H, Xie W, Sun J, Zhang X, Teng Y, Li X, Zhu J, Luo T, Zhao B, Ning F, Xie C, Gan L, Yin G, Li Y, Yuan C, You W, Wu Z, Liu Q, Kong X, Chang J, Zhao J, Zhai Z, Ouyang Q, Han X, Li F, Nie J, Han G, Xia C, Huang W, Xiang S, Zou K, Wang Y, Xu B. Anbenitamab plus HB1801 for HER2-Positive Advanced Breast Cancer. N Engl J Med. 2026 Oct 24. doi: 10.1056/NEJMoa2610345. Online ahead of print.
PubMed 42929681
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT05838066
- Acronym / sponsor ID
- KN026-003
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 May 2023 (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 randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).
Detailed description
The purpose of this study is to assess the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer. This study will establish an independent data monitoring committee (IDMC) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. During the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. In addition, the IDMC plans to conduct one interim analysis of efficacy during the study period.
The primary study hypotheses are that the combination of KN026 combined with HB1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: Progression-free Survival (PFS) as assessed by the BIRC per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KN026+HB1801 | Experimental | Drug: Recombinant Humanized Bispecific antibody against HER2，KN026, Drug: HB1801Subjects will receive an intravenous (IV) infusion of KN026 plus HB1801. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurrs first. |
| Trastuzumab + Pertuzumab + Docetaxel | Active comparator | Drug: Pertuzumab, Drug: Trastuzumab, Drug: DocetaxelOn Day 1 of each 21-day cycle, patients will receive an intravenous (IV) infusion of Pertuzumab 840 mg loading dose followed by 420 mg per cycle, IV, D1, Q3W, in combination with trastuzumab 8 mg/kg loading dose followed by 6 mg/kg per cycle, IV, D1, Q3W and docetaxel 75 mg/m^2. All subjects are required to receive study treatment as planned until investigator-assessed loss of benefit, toxic intolerance, withdrawal of consent, loss to follow-up, or death, whichever occurred first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily enrolled in this study and signed an informed consent form (ICF).
- Age ≥ 18 years.
- Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
- Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
- No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
Key exclusion criteria (4 listed)
- Ineligible for any of the agents on the study
- Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.
- Pregnant or lactating women.
- Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
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 |
|---|---|---|
| Recombinant Humanized Bispecific antibody against HER2，KN026IV infusion | Drug | KN026+HB1801 |
| HB1801IV infusion | Drug | KN026+HB1801 |
| Pertuzumab840 mg loading dose followed by 420 mg per cycle, D1 Q3W, IV infusion | Drug | Trastuzumab + Pertuzumab + Docetaxel |
| Trastuzumab8 mg/kg loading dose followed by 6 mg/kg per cycle, D1 Q3W, IV infusion | Drug | Trastuzumab + Pertuzumab + Docetaxel |
| Docetaxel75 mg/m^2, D1 Q3W, IV infusion | Drug | Trastuzumab + Pertuzumab + Docetaxel |
Primary outcome
Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1).
Time frame: Up to approximately 4 years
9 secondary outcomes
PFS (investigator assessment, RECIST1.1)
Time frame: Up to approximately 4 years
Overall survival (OS)
Time frame: Up to approximately 4 years
Objective response rate (ORR)
Time frame: Up to approximately 4 years
Disease control rate (DCR)
Time frame: Up to approximately 4 years
Duration of response (DoR)
Time frame: Up to approximately 4 years
Frequency and severity of TEAE and SAE
Time frame: Up to approximately 4 years
Concentration of KN026 in serum
Time frame: Up to approximately 4 years
Concentration of HB1801 in serum
Time frame: Up to approximately 4 years
Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 42929681Wang J, Li H, Xu F, Wu T, Tong Z, Cui J, Wang X, Song Z, Sun T, Li H, Xie W, Sun J, Zhang X, Teng Y, Li X, Zhu J, Luo T, Zhao B, Ning F, Xie C, Gan L, Yin G, Li Y, Yuan C, You W, Wu Z, Liu Q, Kong X, Chang J, Zhao J, Zhai Z, Ouyang Q, Han X, Li F, Nie J, Han G, Xia C, Huang W, Xiang S, Zou K, Wang Y, Xu B. Anbenitamab plus HB1801 for HER2-Positive Advanced Breast Cancer. N Engl J Med. 2026 Oct 24. doi: 10.1056/NEJMoa2610345. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Active, not recruitingPhase 3
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
Breast Cancer
Active, not recruitingPhase 3
A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Not yet recruitingPhase 2
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
HER2-positive Recurrent or Metastatic Breast Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Humanized Bispecific antibody against HER2，KN026, HB1801 and Pertuzumab in people with First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer, run by Shanghai JMT-Bio Inc. 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 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: looking for participants now, as of the sponsor's last update on 30 May 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group Officer (+86-0311-69085587, ctr-contact@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1). (time frame: Up to approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05838066, which also lists 1 linked publication.
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 30 May 2025.