A Study of XS-02 Capsules in Patients With Advanced Solid Tumors
NCT Number: NCT06531486
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Solid Tumor|Ovarian Cancer|Breast Cancer|Endometrial Cancer
Interventions: OTHER: XS-02 capsules
Sponsor: NovaOnco Therapeutics Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 96
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2027-08-30

Summary:
A study to evaluate the safety, tolerability, Pharmacokinetics(pk), and efficacy of XS-02 capsules in patients with advanced solid tumors.

Primary Outcome Measures: 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., 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: 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., Through study completion, an average of 3 years
Secondary Outcome Measures: 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., 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), up to 12 weeks|PK parameters(phase I/II), Area under the concentration-time curve from time 0 (pre-dose) to infinity(AUC0-∞), 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), up to 12 weeks|PK parameters(phase I/II), Maximum plasma concentration(Cmax), up to 12 weeks|PK parameters(phase I/II), Time to maximum plasma concentration(Tmax), up to 12 weeks|PK parameters(phase I/II), half-life(t1/2), 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., 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., 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, 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., 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., 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., 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., from first dose to phase I completion, an average of 1.5 years