A Study of WX390 in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WX390.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors
Overview
The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are: * PFS, OS, DoR at week 48; * antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.
Detailed description
This study will be an open-label, multicenter phase II clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. And then patents will be administered for 12 cycles treatment and 30 days safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.
Interventions
- Drug WX390
WX390 tablet, 1.1 mg once a day
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: Week 48]
- Overall Survival (OS) [Time frame: Week 48]
- Duration of Response (DOR) [Time frame: Week 48]
- Progression-free survival rate (PFSR) [Time frame: Week 24 and Week 48]
- Objective Response Rate (ORR) [Time frame: Week 24 and Week 48]
- Disease control rate (DCR) [Time frame: Week 24 and Week 48]
Secondary outcome measures (1)
- Incidence, nature, and severity of adverse events (AEs) [Time frame: Week 24 and Week 48]
Eligibility criteria
Inclusion criteria
- ≥18 years of age
- Histological or cytological confirmed advanced solid tumor, standard regimen failed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of more than 3 months
- At least one measurable lesion according to RECIST 1.1
- Adequate organ function
- Signed and dated informed consent
Exclusion criteria
- Anti-cancer therapy within 30 days prior to the initiation of investigational treatment
- Major surgery within 30 days prior to the initiation of study treatment
- Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)
- Patients who are suffering active interstitial lung disease
- Evidence of ongoing or active serious infection
- Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
- Active hepatitis B or C infection
- Inability to take medication orally
- Abuse of alcohol or drugs
- Pregnant or lactating women
- People with cognitive and psychological abnormality or with low compliance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06117540 · WX390-002