A study to evaluate the safety, tolerability, Pharmacokinetics(pk), and efficacy of XS-02 capsules in patients with advanced solid tumors.
This is a multicenter, open label, single-arm Phase I/II dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic profile, and initial efficacy of XS-02 capsules in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Upon completion of all screening visits, eligible patients will be treated with XS-02 capsules at the appropriate dose.
Occurrence of Dose Limiting Toxicity (DLT) (DLT observation period).(phase I)
DLT is defined as a dose-limiting toxic event that occurs during DLT observation.
Time frame: from first dose up to 31 days
Maximum tolerated dose (MTD) and/or Recommended Phase II Dose(RP2D).(phase I)
MTD is defined as the maximum tolerated dose。RP2D is defined as the recommended dose for Phase II clinical studies
Time frame: Time Frame: from first dose to phase I completion, an average of 1.5 years
Objective Response Rate(ORR)(phase II)
ORR is defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as evaluated according to RECIST version 1.1.
Time frame: Through study completion, an average of 3 years
the incidence and severity of adverse events, serious adverse events, deaths, and safety screening abnormalities(phase I/II)
According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE) version 5.0 evaluates the incidence and severity of adverse events, serious adverse events, deaths, and safety screening abnormalities (such as laboratory tests, vital signs, physical examinations, electrocardiograms, ECOG, etc.). Proportion of patients undergoing dose adjustment or discontinuation due to drug toxicity.
Time frame: From enrollment up to 30 days after last dose
Pharmacokinetics(PK) parameters(phase I/II)
Area under the concentration-time curve from time 0 (pre-dose) to the last measurable time of concentration(AUC0-t)
Time frame: up to 12 weeks
PK parameters(phase I/II)
Area under the concentration-time curve from time 0 (pre-dose) to infinity(AUC0-∞)
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Time frame: up to 12 weeks
PK parameters(phase I/II)
Area under the plasma drug concentration-time curve over a dosing interval at steady state(AUCtau)
Time frame: up to 12 weeks
PK parameters(phase I/II)
Maximum plasma concentration(Cmax)
Time frame: up to 12 weeks
PK parameters(phase I/II)
Time to maximum plasma concentration(Tmax)
Time frame: up to 12 weeks
PK parameters(phase I/II)
half-life(t1/2)
Time frame: up to 12 weeks
Disease Control Rate(DCR)(phase I/II)
DCR is defined as the proportion of patients with confirmed Complete Response(CR), Partial Response(PR), and Stable Disease(SD) based on the Response Evaluation Criteria in Solid Tumors Version 1.1(RECISIT V1.1) evaluation.
Time frame: Through study completion, an average of 3 years
(Clinical Benefit Rate(CBR)(phase I/II)
CBR was defined as the proportion of patients with CR, PR, and SD lasting at least 24 weeks, as evaluated according to RECIST version 1.1.
Time frame: Through study completion, an average of 3 years
Duration of Response(DOR)(phase I/II)
DOR is defined as the time from the date of first documented response (which is subsequently confirmed) until progression per RECIST V1.1 criteria or death due to any cause
Time frame: Through study completion, an average of 3 years
Time to Response(TTR)(phase I/II)
TTR is defined as the time from the first dose to the first confirmed PR or CR evaluated according to RECIST version 1.1.
Time frame: Through study completion, an average of 3 years
Progression Free Survival(PFS)(phase I/II)
PFS is defined as the time until disease progression or death of the first dose, whichever occurs first.
Time frame: Through study completion, an average of 3 years
Overall Survival(OS)(phase I/II)
OS is defined as the time from the first use of the study drug until death from any cause.
Time frame: Through study completion, an average of 3 years
Objective Response Rate(ORR)(phase I)
ORR is defined as the proportion of patients with confirmed Complete Response (CR) or Partial Response (PR) as evaluated according to RECIST version 1.1.
Time frame: from first dose to phase I completion, an average of 1.5 years