This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.
The study will be started with a dose escalation part of ABSK131 administered in repeated 21-day cycles in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors. The expansion part of oral ABSK131 at the recommended dose of expansion (RDE) will be followed to evaluate safety, tolerability, and preliminary antitumor activity among patients with MTAP-Deficient Advanced/Metastatic Solid Tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
266
In the escalation part,patients will first orally receive a single dose of ABSK131 on D-2, followed by a two-day run-in period to assess the PK profile of single-dose ABSK131 administration. Thereafter, patients will continuously receive ABSK131 once daily (QD). In the expansion part, patients will orally receive ABSK131 at the recommended dose for expansion (RDE)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of DLT
Dose-limiting toxicities
Time frame: from Run-in to Day21
AEs
Adverse events
Time frame: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.
AESIs
Adverse events of special interest (AESIs)
Time frame: he date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.
SAEs
Serious adverse events (SAEs)
Time frame: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months
Cmax
Maximum observed concentration
Time frame: From date of enrollment(Run-) until the date of end of treatment visit, assessed up to 30 months
AUC
area under the concentration-time curve
Time frame: From date of enrollment(R) until the date of end of treatment visit, assessed up to 30 months
t1/2
elimination half-life
Time frame: From date of enrollment(Run-in) until the date of end of treatment visit, assessed up to 30 months
CL/F
apparent oral clearance
Time frame: From date of enrollment(Run-in) until the date of end of treatment visit, assessed up to 30 months
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tmax
time to maximum observed concentration
Time frame: From date of enrollment(R) until the date of end of treatment visit, assessed up to 30 months
ORR
Objective response rate
Time frame: From date of enrollment(R)until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first,assessed up to 30 months
DOR
Duration of response
Time frame: From date of enrollment(R)until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first,assessed up to 30 months
PFS
Progression-free survival
Time frame: From date of enrollment(R)until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first,assessed up to 30 months
DCR
Disease control rate
Time frame: From date of enrollment(R)until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first,assessed up to 30 months
OS
Overall survival
Time frame: From date of enrollment(Run-in)until the date of death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first,assessed up to 60 months