Overview
The study is a Phase 1dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors.
Description
A two-part, dose-escalation and expansion study of ASKG915 was initiated to determine the safety, tolerability, PK and PD.
Eligibility
Inclusion Criteria:
- Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- ECOG performance status of ≤ 2.
- Life expectancy of ≥ 3 months.
- The results of the laboratory tests must meet all criteria.
Exclusion Criteria:
- Patients have received antitumor therapy during the first 4 weeks before study drug use.
- Received a live attenuated vaccine within 4 weeks prior to C1D1.
- Known cerebral parenchymal metastasis or meningeal metastasis.
- History of serious cardiovascular or cerebrovascular diseases.
- Active or recurrent autoimmune diseases.
- History of ascites or pleural effusion requiring drainage.
- Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.