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.
Escalation Part: Dose escalation of oral ABSK061 will be guided by the Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified. During the dose escalation part of the study, patients will receive a single dose of ABSK061 on C1D1 only, and then BID dosing for the rest of the days of cycle 1 and in the subsequent cycles. If the actual elimination half-life of ABSK061 is greatly exceeding that predicted, a run-in period with a single-dose and a longer drug-free observation period could be performed in subsequent patients after the Investigator and Sponsor have discussed and agreed. Expansion Part: When health authorities outside US require safety data in local population be provided prior to expansion part, a minimum of 3 local subjects will be enrolled and treated at the selected RDE dose level first in that country/region to evaluate the tolerability of ABSK061. The inclusion and exclusion criteria for escalation part will apply for these subjects. After similar safety and tolerability of ABSK061 in patients in the relevant locality have been confirmed by local Investigators and the Sponsor, additional patients will be allowed to enroll in the expansion part.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
In 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.
Mary Crowley Cancer Research
Dallas, Texas, United States
RECRUITINGYuan LU
Shanghai, Abbisko Therapeutics Co., Ltd. 12B Floor, Building 1, Lane 515, China
RECRUITINGThe First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChongqing Daping Hospital
Chongqing, Chongqing Municipality, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, Gongshu District, China
RECRUITINGSun Yat-sen Memorial Hospital/ the Second Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITING...and 12 more locations
Incidence of DLT
dose-limiting toxicities (DLTs)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Incidence and severity of adverse events (AEs)
adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs)
Time frame: Through study completion, an average of half year
Cmax
maximum observed concentration
Time frame: Through the study completion, an average of half year
Tmax
time to maximum observed concentration
Time frame: Through the study completion, an average of half year
AUC
area under the concentration-time curve
Time frame: Through the study completion, an average of half year
t1/2
half-life
Time frame: Through the study completion, an average of half year
Vz/F
apparent volume of distribution
Time frame: Through the study completion, an average of half year
CL/F
apparent oral clearance
Time frame: Through the study completion, an average of half year
Css_max
maximum observed concentration of steady-state
Time frame: Through the study completion, an average of half year
Css_min
minimum observed concentration of steady/state
Time frame: Through the study completion, an average of half year
AUCss
area under the concentration-time curve of steady/state
Time frame: Through the study completion, an average of half year
Rac
accumulation rate
Time frame: Through the study completion, an average of half year
ORR
Overall response rate
Time frame: Through the study completion, an average of half year
DoR
Duration of response
Time frame: Through the study completion, an average of half year
DCR
Disease control rate
Time frame: from onset of PR or CR to disease progression (up to 100 months)
DoR
Duration of response
Time frame: at 24 weeks
PFS
Progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.