A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors

This study is a study of SPGL-008 monotherapy in patients with advanced malignant tumors. The study includes two cohorts, Cohort 1 and Cohort 2 will be administered by intravenous and subcutaneous administration respectively. Both cohorts will be conducted by the dose-escalation design to evaluate safety, tolerability and preliminary efficacy of different administration of SPGL008.

Inclusion criteria

• Males and/or females, 18-75 years old;
• Histologically and/or cytologically documented advanced or metastatic malignant Tumors;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Expected survival >=3 months;
• Signed informed consent form.

Exclusion criteria

• Known uncontrolled or symptomatic central nervous system metastatic disease;
• Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI-CTCAE] v.5.0);
• Inadequate organ or bone marrow function;
• Pregnant or breast-feeding woman;
• Known allergies, hypersensitivity, or intolerance to SPGL008.