Status:
RECRUITING
A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
Lead Sponsor:
Shanghai Jiatan Pharmatech Co., Ltd
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced solid tumors. The main questions it aims to answer are: ...
Detailed Description
This study will be an open-label, multicenter phase Ib/IIa clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week ...
Eligibility Criteria
Inclusion
- ≥18 years of age
- Histological or cytological confirmed advanced solid tumor, standard regimen failed or no standard regimen available
- 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
- Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose 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
- History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection
- Inability to take medication orally
- Abuse of alcohol or drugs
- People with cognitive and psychological abnormality or with low compliance
- Pregnant or lactating women
Key Trial Info
Start Date :
November 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 9 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06117566
Start Date
November 18 2022
End Date
November 9 2025
Last Update
November 25 2024
Active Locations (1)
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1
the first affiliated hospital of Jilin university
Changchun, Jilin, China, 130000