Solid Tumor
Conditions
Brief summary
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
DRUGWX390
WX390 tablet, 1.1 mg once a day
Sponsors
Shanghai Jiatan Pharmatech Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | Week 48 | DoR, the time from the first occurrence of objective response until disease progression or death from any cause, whichever occurs first. |
| Progression-Free Survival (PFS) | Week 48 | PFS, time from the first dose of trial medication to the first occurrence of disease progression or death due to any cause on study, whichever occurs first. |
| Overall Survival (OS) | Week 48 | OS, time from first dose of trial medication to death due to any cause. |
| Disease control rate (DCR) | Week 24 and Week 48 | DCR, proportion of patients with CR or PR or SD. |
| Progression-free survival rate (PFSR) | Week 24 and Week 48 | PFSR, Percentage of patients alive without progression from baseline. |
| Objective Response Rate (ORR) | Week 24 and Week 48 | ORR, proportion of patients with complete response (CR) or partial response (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence, nature, and severity of adverse events (AEs) | Week 24 and Week 48 | Incidence, nature, and severity of adverse events (AEs) refer to the frequency, type, and level of harm of undesirable effects in clinical trials. Incidence shows how often AEs occur. Nature describes the specific characteristics of AEs, while severity indicates the extent of harm caused. |
Countries
China
Contacts
Primary ContactJiajia Li
Outcome results
None listed