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

Summary

This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease;
2. 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);
3. Inadequate organ or bone marrow function;
4. Pregnant or breast-feeding woman;
5. Known allergies, hypersensitivity, or intolerance to SPGL008.

Conditions2

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