A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors

Who cannot join

• 1. Known symptomatic central nervous system or meningeal metastases, or other evidence of uncontrolled central nervous system or meningeal metastases as judged by the investigator; stable central nervous system or meningeal metastases are allowed; 2. Previous treatment with HER3-targeting ADC; 3. Adverse reactions from previous anti-tumor treatments that have not recovered to ≤ Grade 1 according to CTCAE 5.0 (excluding toxicities deemed not a safety risk by the investigator, such as alopecia); 4. Receipt of antibody-based macromolecule therapy, definitive radiotherapy, immunotherapy within 28 days before the first dose, or chemotherapy, small molecule targeted therapy, palliative radiotherapy, hormone therapy, or traditional Chinese medicine with anti-tumor indication effects within 14 days or 5 half-lives (whichever is longer) before the first dose; 5. Concurrent participation in another clinical trial, unless it is an observational (non-interventional) clinical trial or in the follow-up period of an interventional trial; 6. Receipt of major surgery or invasive intervention within 28 days before the first dose; 7. Known severe allergic reactions to the investigational intervention or any of its components or excipients; 8. Active bacterial, fungal, or viral infection requiring intravenous antibacterial, antifungal, or antiviral treatment before the first dose. Participants receiving prophylactic infection treatment without active infection symptoms may be considered for inclusion; 9. Uncontrolled serous cavity effusion (e.g., pleural effusion, ascites, pericardial effusion, etc.) requiring frequent drainage or medical intervention within 7 days before the first dose, excluding exfoliation cytology of exudate; 10. History of immunodeficiency, including Human immunodeficiency virus (HIV) antibody positivity; 11. Hepatitis B Surface Antigen (HBsAg) positive with Hepatitis B Virus (HBV)-DNA higher than the lower limit of detection or 1000 copies/mL (500 IU/mL) (whichever is lower), Hepatitis C virus (HCV) antibody positive with HCV-RNA higher than the lower limit of detection or 1000 copies/mL (whichever is lower); 12. Severe cardiovascular disease history, including but not limited to:
• Severe cardiac arrhythmia or conduction abnormality requiring clinical intervention, such as ventricular arrhythmia, grade II-III atrioventricular block, etc.;
• Average QT interval corrected by Fridericia's formula (QTcF) > 450 ms on three resting 12-lead Electrocardiogram;
• Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events within 6 months before the first dose;
• New York Heart Association (NYHA) classification ≥ Class II;
• Any factors increasing the risk of QTc prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relatives under 40 years old, concomitant use of drugs known to prolong QT interval;
• Uncontrolled hypertension (screening systolic BP ≥ 160 mmHg and/or diastolic Blood Pressure (BP) ≥ 100 mmHg); 13. Drug-induced colitis, or history of hormone-requiring interstitial lung disease/pneumonitis or current suspicion of interstitial lung disease/pneumonitis on screening imaging; 14. Evidence of gastrointestinal bleeding or perforation risk, or pyloric obstruction, persistent recurrent vomiting (defined as vomiting ≥ 3 times within 24 hours), deemed unsuitable for inclusion by the investigator; 15. Use of or need for strong Recombinant Human CYP3A4 Enzyme (CYP3A4) inducers or inhibitors, Organic Anion Transporting Polypeptides 1B1 (OATP1B1) or Organic Anion Transporting Polypeptides 1B3 (OATP1B3) inhibitors within 5 half-lives before the first dose or during the study; 16. Current psychiatric disorder affecting compliance; 17. Exclusion of those on long-term immunosuppressive therapy or requiring daily systemic steroid treatment, except for topical glucocorticoid treatment via nasal, inhalation, or other routes; 18. Pregnant or breastfeeding women; 19. Other reasons deemed unsuitable for participation by the investigator.