This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.
Patient should understand, sign, and date the written informed consent form prior to screening.
Male or female age 18 years or older.
For escalation part: patients with histologically confirmed solid tumors who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
Patients with histologically confirmed urothelial carcinoma or cholangiocarcinoma who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
Known allergy or hypersensitivity to any component of the investigational product
For expansion part only: Previous treatment with FGFR pathway inhibitors or multi-kinase inhibitors which target FGFR inhibition (recommend to consult with sponsor)
Has a known additional malignancy that is progressing or has required active treatment.
Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication
Sequential
ABSK061
DrugIn the escalation part, patients will receive a single dose of oral ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in subsequent cycles (28-day cycles). The starting dose is 5 mg BID. In the expansion part, patients will each receive oral ABSK061 at the RDE in repeated 28-day cycles.
Incidence of DLT
dose-limiting toxicities (DLTs)
Incidence and severity of adverse events (AEs)
adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
Cmax
maximum observed concentration
Tmax
time to maximum observed concentration
AUC
area under the concentration-time curve
t1/2
half-life
Click on the lead sponsor to view all of their trials.
