A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
Shanghai Jiatan Pharmatech Co., Ltd
100 participants
Nov 18, 2022
INTERVENTIONAL
Conditions
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: * the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of WX390; * safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.
Eligibility
Inclusion Criteria7
- ≥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 Criteria11
- 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
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Interventions
WX390 tablet, once a day
240 mg, Day 1, every 3 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06117566