Status:
RECRUITING
A Study of WX390 in Patients With Advanced Solid Tumors
Lead Sponsor:
Shanghai Jiatan Pharmatech Co., Ltd
Conditions:
Solid Tumor
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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; * antitumo...
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 scre...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
May 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 12 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06117540
Start Date
May 11 2021
End Date
June 12 2026
Last Update
November 19 2024
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000