Advanced Breast CancerPhase 2NCT07597629
A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer
A Phase 2 study testing SYS6023 and KN026 in people with Advanced Breast Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.
Trial summary
This is an open-label, multicenter Phase II clinical study conducted 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
- Advanced Breast Cancer
- What is being tested?
- SYS6023 and KN026
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2026to 30 May 2029
- Phase
- Phase 2
- 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
- 1. Age ≥ 18 years old;
- 2. Histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer:
- 3. Sufficient tumor specimens must be provided for biomarker testing (human epidermal growth factor receptor 3-HER3), preferably obtained during or after the most recent treatment period; During safety run-in period, subjects who cannot provide sufficient tissue samples may be screened after sponsor's evaluation and approval;
- 4. Documented disease progression or intolerability with the most recent systemic anti-tumor treatment;
- 5. According to RECIST 1.1, at least one evaluable lesion (safety run-in period) or measurable lesion (cohort expansion phase);
- 6. ECOG PS score 0-1;
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- 7. Expected survival ≥ 3 months;
- 8. Adequate organ function with laboratory tests meeting criteria (no blood transfusion or hematopoietic growth factor therapy within 14 days before testing): ANC ≥ 1.5 × 10^9/L PLT ≥ 100 × 10^9/L Hb ≥ 90 g/L TBIL ≤ 1.5 × ULN ALT, AST ≤ 2.5 × ULN; for participants with liver metastasis, ALT and AST ≤ 5 × ULN Creatinine clearance rate (Ccr) > 35 mL/min (calculated according to Cockcroft-Gault formula) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN Left ventricular ejection fraction (LVEF) ≥ 55% (only applicable to Cohort 2)
- 9. Eligible individuals with reproductive potential must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the trial and for at least 7 months after the last dose; Women of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment;
- 10. Fully understand this clinical trial and voluntarily sign the written informed consent form.
Who cannot join
- 1. Prior treatment with HER3-targeted ADC therapy;
- 2. Applicable to Cohort 1: a. Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy; b. Current presence or impending visceral crisis that has caused or may cause impending organ damage and/or other life-threatening complications;
- 3. Applicable to Cohort 2: a. Prior exposure to anthracyclines with cumulative dose exceeding 360 mg/m^2doxorubicin equivalent; b. LVEF once dropped to < 40% during prior anti-HER2 drug therapy, or symptomatic CHF occurred;
- 4. History of other malignancies within 3 years before randomization/first dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll);
- 5. Untreated (including those detected during screening period) or unstable brain parenchymal metastasis, spinal cord metastasis or compression, carcinomatous meningitis. Subjects with treated stable brain metastases may be considered for enrollment (Note: refers to participants who have received local brain treatment, whose symptoms are stable, imaging tests show stability for at least 28 days before randomization/first dose, no evidence of progressive brain edema, and no need for glucocorticoids or other symptom control measures);
- 6. Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk);
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- 7. Major surgery within 28 days before randomization/first dose, or planned to undergo systemic or local tumor resection during the study period;
- 8. History of severe bleeding risk (e.g., gastrointestinal varices) or bleeding diathesis, any gastrointestinal bleeding or other bleeding of ≥ CTCAE grade 2 within 28 days before randomization/first dose; Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before randomization/first dose;
- 9. History of severe cardiovascular disease, including but not limited to:
- Acute coronary syndrome within 6 months before randomization/first dose;
- Stroke or transient ischemic attack within 6 months before randomization/first dose;
- Pulmonary embolism or deep vein thrombosis within 3 months before randomization/first dose (intermuscular vein thrombosis may be enrolled if assessed as low risk by researchers);
- CHF with NYHA functional classification ≥ II;
- Documented history of cardiomyopathy that has not currently recovered;
- Pericarditis;
- Severe arrhythmia, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.;
- Baseline average QTcF > 450 ms (calculated using Fridericia formula), or history or family history of long QT syndrome;
- Uncontrolled hypertension (defined as persistent systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication);
- 10. Presence of non-infectious lung disease/pneumonia requiring treatment at randomization/first dose, or history of interstitial lung disease/pneumonia requiring glucocorticoid treatment during prior anti-tumor therapy;
- 11. Active bacterial, fungal or viral infection within 14 days before randomization/first dose (defined as requiring intravenous anti-bacterial, anti-fungal or anti-viral drug therapy). Individuals receiving prophylactic anti-infective therapy without clinical manifestations of active infection may be considered for enrollment;
- 12. Active hepatitis B or hepatitis C, defined as HBsAg positive and HBV DNA > 2000 IU/mL for active hepatitis B; defined as HCV-Ab positive and HCV RNA > ULN for active hepatitis C;
- 13. History of immunodeficiency or positive HIV antibody test during screening;
- 14. Use of strong CYP3A4 inducers or inhibitors, OATP1B1 or OATP1B3 inhibitors before randomization/first dose (within 5 half-lives of inducer or inhibitor) or need to use such drugs during study treatment;
- 15. Known or suspected hypersensitivity to the study drug or its components;
- 16. Lactating women;
- 17. Presence of other conditions that may interfere with participants' participation in study procedures, not in line with participants' maximum benefit from participating in the study, or affect study results: such as history of mental illness, drug abuse or substance abuse, any other clinically significant disease or condition, 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
Affiliated Tumor Hospital of Harbin
Harbin, Heilonjiang, 150000
Qingyuan Zhang, M.D., +86-13313612989, sy86298276@163.com
About this study
Official title: A Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6023 Combination Therapy for Unresectable Locally Advanced or Metastatic Breast Cancer
This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.
Read the detailed description
This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.
The study aims to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of SYS6023 in combination with other agents in subjects with advanced breast cancer.
Eligible subjects will receive SYS6023 in combination with HB1901 or KN026, with each treatment cycle lasting 3 weeks, until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.
- Conditions
- Advanced Breast Cancer
- Being tested
- SYS6023, KN026
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6023Drug
SYS6023 is a novel antibody-drug conjugate (ADC) targeting HER3, administered via intravenous infusion.
KN026Drug
KN026 is an antibody targeting HER2, administered via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| SYS6023 in combination with KN026 | Experimental | Patients with advanced breast cancer receiving SYS6023 in combination with KN026 treatment. Receives: Drug: SYS6023; Drug: KN026 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose-limiting toxicity (DLT)
Measured: At the end of Cycle 1 (each cycle is 21 days).
Frequency and severity of AEs and SAEs (according to NCI-CTCAE 6.0);
Measured: Baseline up to 28 days post last dose, Up to approximately 3 years
Recommended Phase 2 Dose（RP2D）
Measured: Up to approximately 3 years
Objective Response Rate (ORR)
Measured: Up to approximately 3 years
Secondary outcomes (11)
Maximum Plasma Concentration( Cmax)
Measured: Up to approximately 3 years
Time to Maximum Plasma Concentration (Tmax)
Measured: Up to approximately 3 years
Area Under the Serum Concentration Time Curve ( AUC)
Measured: Up to approximately 3 years
Elimination half-life (t1/2)
Measured: Up to approximately 3 years
Anti-Drug Antibody（ADA）
Measured: Up to approximately 3 years
Disease control rate (DCR)
Measured: Up to approximately 3 years
Duration of Response (DoR)
Measured: Up to approximately 3 years
Progression-Free-Survival (PFS)
Measured: Up to approximately 3 years
Overall survival (OS)
Measured: Up to approximately 3 years
Expression level of tumor markers
Measured: Up to approximately 3 years
Plasma drug concentration
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start25 May 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Receiving SYS6023 in combination with KN026.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qingyuan Zhang, M.D., Principal investigator, Affiliated Tumor Hospital of Harbin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597629
- Sponsor's protocol ID
- SYS6023-002
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 16 Jun 2026
- 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 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6023 Combination Therapy for Unresectable Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07597629
- Acronym / sponsor ID
- SYS6023-002
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 19 May 2026 (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 Phase II clinical study conducted in subjects with advanced breast cancer.
Detailed description
This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.
The study aims to evaluate the safety/tolerability, pharmacokinetics, and preliminary efficacy of SYS6023 in combination with other agents in subjects with advanced breast cancer.
Eligible subjects will receive SYS6023 in combination with HB1901 or KN026, with each treatment cycle lasting 3 weeks, until disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, or death, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Receiving SYS6023 in combination with KN026.
| Arm | Type | Receives |
|---|---|---|
| SYS6023 in combination with KN026 | Experimental | Drug: SYS6023, Drug: KN026Patients with advanced breast cancer receiving SYS6023 in combination with KN026 treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Age ≥ 18 years old;
- 2. Histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer:
- 3. Sufficient tumor specimens must be provided for biomarker testing (human epidermal growth factor receptor 3-HER3), preferably obtained during or after the most recent treatment period; During safety run-in period, subjects who cannot provide sufficient tissue samples may be screened after sponsor's evaluation and approval;
- 4. Documented disease progression or intolerability with the most recent systemic anti-tumor treatment;
- 5. According to RECIST 1.1, at least one evaluable lesion (safety run-in period) or measurable lesion (cohort expansion phase);
Key exclusion criteria (26 listed)
- 1. Prior treatment with HER3-targeted ADC therapy;
- 2. Applicable to Cohort 1: a. Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy; b. Current presence or impending visceral crisis that has caused or may cause impending organ damage and/or other life-threatening complications;
- 3. Applicable to Cohort 2: a. Prior exposure to anthracyclines with cumulative dose exceeding 360 mg/m^2doxorubicin equivalent; b. LVEF once dropped to < 40% during prior anti-HER2 drug therapy, or symptomatic CHF occurred;
- 4. History of other malignancies within 3 years before randomization/first dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll);
- 5. Untreated (including those detected during screening period) or unstable brain parenchymal metastasis, spinal cord metastasis or compression, carcinomatous meningitis. Subjects with treated stable brain metastases may be considered for enrollment (Note: refers to participants who have received local brain treatment, whose symptoms are stable, imaging tests show stability for at least 28 days before randomization/first dose, no evidence of progressive brain edema, and no need for glucocorticoids or other symptom control measures);
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 |
|---|---|---|
| SYS6023SYS6023 is a novel antibody-drug conjugate (ADC) targeting HER3, administered via intravenous infusion. | Drug | SYS6023 in combination with KN026 |
| KN026KN026 is an antibody targeting HER2, administered via intravenous infusion. | Drug | SYS6023 in combination with KN026 |
Primary outcome
The incidence of dose-limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days).
Frequency and severity of AEs and SAEs (according to NCI-CTCAE 6.0);
Time frame: Baseline up to 28 days post last dose, Up to approximately 3 years
Recommended Phase 2 Dose（RP2D）
Time frame: Up to approximately 3 years
Objective Response Rate (ORR)
Time frame: Up to approximately 3 years
11 secondary outcomes
Maximum Plasma Concentration( Cmax)
Time frame: Up to approximately 3 years
Time to Maximum Plasma Concentration (Tmax)
Time frame: Up to approximately 3 years
Area Under the Serum Concentration Time Curve ( AUC)
Time frame: Up to approximately 3 years
Elimination half-life (t1/2)
Time frame: Up to approximately 3 years
Anti-Drug Antibody（ADA）
Time frame: Up to approximately 3 years
Disease control rate (DCR)
Time frame: Up to approximately 3 years
Duration of Response (DoR)
Time frame: Up to approximately 3 years
Progression-Free-Survival (PFS)
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 3 years
Expression level of tumor markers
Time frame: Up to approximately 3 years
Plasma drug concentration
Time frame: Up to approximately 3 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 16 Jun 2026.
- 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.
Qingyuan Zhang, M.D. principal investigator
Affiliated Tumor Hospital of Harbin
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 SYS6023 and KN026 in people with Advanced Breast Cancer, run by CSPC Megalith Biopharmaceutical 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 10 inclusion and 26 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 16 Jun 2026. 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?
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@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 21 days).). The study lists 4 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 16 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.