Advanced Solid Tumor Clinical Trial
Official title:
An Open-label, Multi-center, Dose-escalation and Dose-finding, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SKI- G-801 as Monotherapy in Patients With Advanced Solid Tumors
This is a phase I study intended to determine the MTD and RP2D of SKI-G-801 monotherapy by assessing the safety and tolerability including dose-limiting toxicity (DLT) at various dose levels and to explore the efficacy and PK in patients with advanced solid tumors.
This is an open-label, monotherapy study in patients with advanced solid tumors, to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple ascending doses of SKI-O-801(Denfivontinib). A total of 36 subjects are planned to participate in 6 cohorts (traditional 3+3 design). In each cohort, 3 subjects will receive SKI-O-801. Dosing will be initiated with a 100 mg once daily (QD) dose cohort and escalated to 500 mg QD. After 1 cycle (28 days) of treatment if 3 subjects in each cohort have no DLT(Dose Limiting Toxicity), escalate the next dose level by Safety Review Committee decision. ;
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