A Study of XS-02 Capsules in Patients With Advanced Solid Tumors
- Conditions
- Solid TumorEndometrial CancerBreast CancerOvarian Cancer
- Interventions
- Other: XS-02 capsules
- Registration Number
- NCT06531486
- Lead Sponsor
- NovaOnco Therapeutics Co., Ltd.
- Brief Summary
A study to evaluate the safety, tolerability, Pharmacokinetics(pk), and efficacy of XS-02 capsules in patients with advanced solid tumors.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 96
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase I dose escalation/Phase II dose expansion XS-02 capsules Experimental: XS-02 Dosage form:capsule Specification: 5mg，25mg Dose: Phase I dose escalation, orally, once daily, the administration schedule (including dose,administration frequency/interval, administration cycle, etc.) can be adjusted according to the experimental data. Phase II Dose Expansion/Optimal Dose selection, will be determined based on the Phase I dose escalation results. Method of administration: Oral
- Primary Outcome Measures
Name Time Method Occurrence of Dose Limiting Toxicity (DLT) (DLT observation period).(phase I) from first dose up to 31 days DLT is defined as a dose-limiting toxic event that occurs during DLT observation.
Maximum tolerated dose (MTD) and/or Recommended Phase II Dose(RP2D).(phase I) Time Frame: from first dose to phase I completion, an average of 1.5 years MTD is defined as the maximum tolerated dose。RP2D is defined as the recommended dose for Phase II clinical studies
Objective Response Rate（ORR）(phase II) Through study completion, an average of 3 years 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.
- Secondary Outcome Measures
Name Time Method the incidence and severity of adverse events, serious adverse events, deaths, and safety screening abnormalities(phase I/II) From enrollment up to 30 days after last dose 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.
（Clinical Benefit Rate(CBR)(phase I/II) Through study completion, an average of 3 years 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.
PK parameters(phase I/II) up to 12 weeks half-life(t1/2)
Overall Survival（OS）(phase I/II) Through study completion, an average of 3 years OS is defined as the time from the first use of the study drug until death from any cause.
Pharmacokinetics(PK) parameters(phase I/II) up to 12 weeks Area under the concentration-time curve from time 0 (pre-dose) to the last measurable time of concentration(AUC0-t)
Disease Control Rate(DCR)(phase I/II) Through study completion, an average of 3 years 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.
Duration of Response（DOR）(phase I/II) Through study completion, an average of 3 years 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 to Response（TTR）(phase I/II) Through study completion, an average of 3 years TTR is defined as the time from the first dose to the first confirmed PR or CR evaluated according to RECIST version 1.1.
Progression Free Survival（PFS）(phase I/II) Through study completion, an average of 3 years PFS is defined as the time until disease progression or death of the first dose, whichever occurs first.
Objective Response Rate（ORR）(phase I) from first dose to phase I completion, an average of 1.5 years 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.