A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6088 in Patients With Advanced/Metastatic Solid Tumors

Korábbi kezelés

• Subjects with central nervous system metastasis or meningeal metastasis. Patients who have undergone targeted radiotherapy or surgical treatment and have no clinical symptoms and signs without drug symptomatic treatment can be enrolled;
• Adverse reactions of previous anti-tumor treatment (including radiotherapy) have not recovered to CTCAE 6.0 ≤ Grade 1;
• Occurrence of grade ≥3 immune-related adverse events (irAEs), or treatment discontinuation due to immune-related adverse events previously.
• Received chemotherapy, biological therapy, targeted therapy and other anti-tumor treatments within 21 days before the first administration of the study drug;
• Received live or live-attenuated vaccines within 28 days prior to the first administration of study drug or planned to receive during the study;
• Use of immunosuppressive drugs within 14 days before the first administration of study drug;
• Use drugs with anticoagulant effects within 14 days before the first administration of study drug.
• Received palliative treatment for local lesions (including local radiotherapy or other local treatments) within 14 days before the first administration of study drug;
• Have undergone major surgery (excluding puncture biopsy) or severe traumatic injury 28 days before the first administration of study drug;
• Lactating or pregnant women; women of childbearing potential have a positive blood pregnancy test within 7 days prior to trial enrollment; [A participant is of childbearing potential (judged by the investigator) when he/she is biologically capable of fathering a child and is sexually active. Female participants who are not of childbearing potential (i.e., meet at least 1 of the following criteria): have had a hysterectomy or bilateral oophorectomy, or have medically confirmed ovarian failure, or are medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months without a pathological or physiological cause).]

Más betegség

• Subjects with a history of severe allergies; Known hypersensitivity or intolerance to any component of the antibody drug and its excipients;
• Patients with tumor invasion of important arteries leading to high risk of bleeding, obvious risk of perforation, or fistula formation; presence of diseases with impaired wound healing ability;
• Diagnosed with a second primary malignant tumor within 5 years before the first administration of the study drug; Except for effectively treated basal cell carcinoma of skin, squamous cell carcinoma of skin, and/or effectively resected cervix cancer and/or breast cancer in situ;
• Subjects with a history of severe cardiovascular disease；
• History or presence of interstitial pneumonia/lung disease;
• History or presence of inflammatory bowel disease
• History of autoimmune diseases;
• History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or organ transplantation;
• Infectious diseases requiring systemic anti-infective treatment;
• Active hepatitis B; Hepatitis C infection; Active syphilis infection, active tuberculosis;
• Other conditions that the investigator believes will affect the safety or compliance of the study drug treatment, including but not limited to: mental illness, any severe or uncontrolled disease, etc

Egyéb

• Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
• Any male and female participants of childbearing potential who refuse to use effective contraceptive methods throughout the trial and within half a year after the last administration;

• Age ≥ 18 years
• Malignant solid tumors confirmed by histology or cytology
• Patients who have failed standard anti-tumor treatment (disease progression or intolerance), have no available standard treatment or refuse standard treatment. (Phase 1)
• At least one measurable lesion that meets RECIST 1.1 criteria at baseline (the measurable lesion area has not received radiotherapy previously, or there is evidence that the lesion has clearly progressed after the end of radiotherapy) exists
• ECOG PS score ranges 0-1
• Expected survival period ≥ 3 months
• Adequate organ function.
• Participants must give informed consent to this study before the trial and voluntarily sign a written informed consent form.