Advanced Solid Tumors
Conditions
Interventions
Dose Escalation Phase: SYS6010:SYS6010
Dose Expansion Phase:SYS6010:SYS6010
Sponsors
Fujian Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, no gender restriction. 2. Patients with pathologically confirmed advanced solid tumors (including but not limited to squamous cell lung cancer, non-squamous non-small cell lung cancer, nasopharyngeal carcinoma, esophageal cancer, gastric cancer, colorectal cancer, cholangiocarcinoma, pancreatic cancer, breast cancer, cervical cancer, etc.) who meet one of the following criteria: failure of standard treatment, intolerance to standard treatment, no standard treatment available, or refusal of standard treatment. 3. Availability of tumor tissue samples for EGFR expression testing, with positive EGFR expression confirmed by central laboratory testing. - For the dose-escalation phase, prior EGFR-positive expression results approved by the sponsor are acceptable, provided samples are available for retrospective analysis. - For the dose-expansion phase, prior results from the specified central laboratory using the same methodology are acceptable. 4. At least one measurable lesion confirmed by CT or MRI as defined by RECIST v1.1 criteria. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 6. Estimated life expectancy >= 3 months. 7. Adequate major organ function within 7 days prior to treatment, meeting the following criteria: - **Hematology:** Did not receive component blood transfusions, human granulocyte colony-stimulating factor (G-CSF), thrombopoietin (TPO), interleukin-11, and erythropoietin (EPO) within 2 weeks prior to initial administration of the investigational drug. - Absolute neutrophil count (ANC) >= 1.5×10?/L - Platelet count (PLT) >= 100×10?/L - Hemoglobin (HGB) >= 90 g/L or >= 5.6 mmol/L - **Renal Function:** - Serum creatinine (Cr) = 50 mL/min (calculated using the Cockcroft-Gault formula). - Proteinuria: Qualitative =2+, 24-hour urine protein quantification 1.5 is acceptable if deemed clinically stable and without bleeding by the investigator). 8. Subjects must agree to use effective contraception from the time of informed consent until 6 months after the last dose of study treatment. During this period, female subjects must not breastfeed, and male subjects must refrain from sperm donation. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days before the first dose of the investigational product. 9. Voluntary participation in this clinical study, with an understanding of the study procedures and the ability to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Active central nervous system (CNS) metastases and/or leptomeningeal metastases. Patients with supratentorial and/or cerebellar metastases (excluding midbrain, pons, or medulla oblongata) may be included if they have achieved stability following local treatment for at least 2 weeks prior to the first dose of the investigational drug (no new brain metastases or progression of existing lesions on imaging, with stable or normalized neurological symptoms) and do not require corticosteroid therapy or are on a stable daily dose of prednisone = 10 mg or equivalent. 2. History of other malignancies within 3 years prior to the first dose of the investigational drug, except for the following: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, or carcinoma in situ of the cervix. 3. Known hypersensitivity to any component of SYS6010 or to humanized monoclonal antibody products. 4. Prior treatment with EGFR ADC drugs containing topoisomerase I inhibitor payloads. 5. Adverse events from prior anti-tumor therapies not resolved to 10 mg/day or equivalent): at least 2 weeks. - Intravenous antibiotics, antifungals, or antivirals: at least 2 weeks. - Investigational drugs, attenuated live vaccines: at least 4 weeks. - CYP3A4 strong inducers or inhibitors, OATP1B1 or OATP1B3 inhibitors: at least 2 weeks. 7. Severe cardiovascular disease within 6 months prior to the first dose of the investigational drug, including but not limited to: - Severe arrhythmias or conduction disorders requiring clinical intervention (e.g., ventricular arrhythmias, third-degree atrioventricular block); QTcF interval >= 450 ms for males or >= 470 ms for females (corrected using Fridericia's formula: QTcF = QT/RR^0.33, where RR = 60/heart rate). - History of myocardial infarction, unstable angina, angioplasty, or coronary artery bypass grafting. - New York Heart Association (NYHA) Class II or higher heart failure; left ventricular ejection fraction (LVEF) < 50% during screening. 8. History of interstitial lung disease (ILD)/non-infectious pneumonia requiring corticosteroid treatment, current ILD/non-infectious pneumonia, or imaging findings suggestive of ILD/non-infectious pneumonia during screening. 9. Severe infections within 4 weeks prior to the first dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, or active tuberculosis. 10. History of EGFR-targeted therapy interruption =1 month or permanent discontinuation due to skin toxicity, or current skin disorders requiring oral or intravenous treatment. 11. Ophthalmic history of severe dry eye syndrome, severe keratitis, severe conjunctivitis, or other conditions deemed by the investigator to pose a risk of cornea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limited toxicities;Maximum Tolerated Dose;Recommended Phase II Dose;investigator-assessed objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactRongbo Lin
Fujian Provincial Cancer Hospital
Outcome results
None listed