This study is a multi-center, open-label, dose-escalation, dose-expansion, and cohort-expansion first-in-human Phase 1/2 study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of SYS6088 in patients with advanced/metastatic solid tumors.
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
Subjects with a history of severe allergies; Known hypersensitivity or intolerance to any component of the antibody drug and its excipients;
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;
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;
Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
Single group
SYS6088
DrugSYS6088, administered per protocol.
Regorafenib
DrugRegorafenib, administered per protocol.
Ivonescimab
DrugIvonescimab, administered per protocol.
10
Treatment groupsSee each treatment group below.
The occurrence and frequency of Dose-limiting toxicities (DLTs) DLTs during the study
Phase Ⅰ
The occurrence and frequency of Treatment-emergent adverse events (TEAEs)
Phase Ⅰ
The maximum tolerated dose (MTD) of SYS6088 (MTD, if any)
Phase Ⅰ
The recommended Phase 2 dose (RP2D) of SYS6088
Phase Ⅰ
Plasma concentration and pharmacokinetic parameters after single and multiple doses ofSYS6088
Phase l,Cmax
Plasma concentration and pharmacokinetic parameters after single and multiple doses ofSYS6088
Phase l, Tmax etc.
The incidence and titer of Anti-SYS6088 antibody (if applicable);
Phase Ⅰ
The titer of Anti-SYS6088 neutralizing antibody (if applicable);
Phase Ⅰ
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This trial is not recruiting at the moment. You can still explore other options:
