A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor

Conditions

ABSK-011 — DRUG
During the escalation part, the administration of oral ABSK-011 will be guided by "3+3"design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data. A separate food effect cohort may be conducted. In expansion part, patients will be treated at the selected RDE dose level.

This is an open-label phase 1 study with an escalation part and an expansion part.

Experimental: ABSK-011
During the escalation part, all patients will first receive a single dose ABSK-011 (run-in period) at Day -2 and be followed by a 1-day off (2 days in all for run-in period) to access the PK of single-dose. Then, patients will continuously receive ABSK-011 once daily (QD) or twice daily (BID) in repeated 28-day cycles. Dose escalation will employ a "3+3" design except for the patient in the accelerated titration cohort. In expansion part, patients will be treated at the selected RDE dose level.

Incidence of DLT [ Time Frame: From the starting dosing of study drug to the end of Cycle 1 (each cycle is 28 days) in escalation Part ]

Facility	City	State	ZIP	Site coordinators
Mayo Clinic	Phoenix	Arizona	85054	Mitesh J. Borad, MD 855-776-0015
Mayo Clinic	Jacksonville	Florida	32224	Hani M. Babiker, MD 855-776-0015
Moffitt Cancer Center	Tampa	Florida	33612	Richard Kim, MD O'Neke Nickle O'[email protected]
Mayo Clinic	Rochester	Minnesota	55905	Nguyen H. Tran, MD 855-776-0015
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Max Sung, MD [email protected]
MD Anderson Cancer Center	Houston	Texas	77030	Sunyoung Lee, MD [email protected]

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