Advanced Urothelial Cancer and other Advanced Solid Tumors
Conditions
Interventions
Test group:SYS6002+SG001
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, regardless of gender; 2. In the dose - selection phase, participants are patients with late - stage solid tumors confirmed pathologically. They have failed standard treatment, or are ineligible for it, or have no standard treatment. In the dose - expansion phase, participants are pathologically confirmed patients with locally advanced or metastatic urothelial carcinoma. They shouldn't have received systemic anti - tumor treatment. If they had neoadjuvant or adjuvant therapy before, there should be over 12 months from its end to disease progression (radiologically confirmed) to be eligible; 3. Able to provide well-preserved or fresh tumor tissue; 4. According to the Solid Tumor Efficacy Evaluation Standard (RECIST) v1.1, at least one measurable lesion confirmed by CT or MRI; 5. The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-1; 6. Expected survival time >= 3 months; 7. Major organ function within 7 days prior to the first use of the trial drug, meeting the following criteria (no component transfusion, G-CSF, TPO, IL-11, EPO within 2 weeks before the first dose of the trial drug): a) Blood routine: NEUT>= 1.5×10^9 /L, PLT>= 100×10^9 /L; Hemoglobin >= 90g/L or >= 5.6mmol/L. b) Ccr>= 50 mL/min (according to Cockcroft and Gault formula). c) Liver function: total bilirubin (TBIL<= 1.5 ULN), ALT and AST <= 3 ULN, and both AST and ALT <= 5.0 ULN in liver metastases, d) Coagulation function: INR<= 1.5, APTT<= 1.5ULN; 8. Subjects with Fertility should use contraceptives (such as Intrauterine device [IUD], contraceptives or condoms) during the study period and within 6 months after the end of the study, and men should avoid sperm donation; Women of childbearing age had negative serum Pregnancy test within 7 days before the study was included, and must be non-lactating women; 9. Volunteer to participate in this clinical study, understand the research procedures, and be able to sign an informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1.With active central nervous system (CNS) metastasis and/or leptomeningeal metastasis. ;If metastasis of the central nervous system (CNS) is limited to the supratentorial area and/or cerebellum (with no metastasis in the midbrain, pons, medulla or spinal cord), and the patient has undergone local therapy, and neurological symptoms have been stable at least 2 weeks before the first use of the trial drug, and no steroid therapy is needed or the patient is on 480 ms by Fridericia method (Fridericia formula: QTcF = QT/RR0.33, RR = 60/heart rate); 2) With history of myocardial infarction, unstable angina pectoris, angioplasty and coronary artery bypass surgery; 3) Grade III and above heart failure by New York Heart Association (NYHA) classification; in the tests and examinations during the screening period, left ventricular ejection fraction (LVEF) = 8%; 2) With active keratitis and corneal ulcer; 3) With >= Grade 2 neuropathy before the first dose of the investigational drug; 4) Severe infection within 4 weeks before the first use of the test drug, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.Active infection requiring systemic antibiotics within 2 weeks prior to the first dose of trial drug; 5) Active HBV or HCV infection (HBV-DNA >= 2000 IU/mL or 10^4 copies/mL, HCV antibody positive and HCV RNA higher than the lower limit of detection of the analytical method, note: for patients who are positive for HBsAg, it is recommended to start antiviral therapy before the first use of the test drug, for example nucleoside analogues, such as entecavir and tenofovir disoproxil); 6) Those with a history of immunodeficiency (HIV-positive, acquired or congenital immunodeficiency, etc.), or organ transplantation; 7) History of severe allergic reaction to monoclonal antibody preparations and history of uncontrollable allergic asthma; 8) Participants with active autoimmune disease or a history of autoimmune disease, but further enrollment screening is permitted for participants with the following diseases: well-controlled type I diabetes mellitus, well-controlled hypothyroidism that requires hormone replacement therapy only, skin disease that does not require systemic treatment (such as vitiligo, psoriasis, or alopecia), or participants whose condition is not expected to recur in the absence of external triggers; 9) Any other malignant tumor within 5 years before the first dose of the investigational drug, except for cured skin basal cell carcinoma and cervical carcinoma in situ after surgery; 10) History of interstitial lung disease (ILD)/non-infectious pneumonitis requiring glucocorticoid therapy,Those who currently have ILD/non-infectious pneumonitis, or who cannot be excluded from
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event (AE);Serious Adverse Event (SAE);Recommended dose for SYS6002 in combination with SG001;Objective Response Rate(ORR); | — |
Countries
China
Contacts
Public ContactYe Dingwei
Fudan University Shanghai Cancer Center
Outcome results
None listed