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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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.
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 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).
Disease control rate (DCR) — Week 24 and Week 48 DCR, proportion of patients with CR or PR or SD.
Trial sites (1)
Facility
City
Region
Status
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
Recruiting
More Shanghai Jiatan Pharmatech Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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