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
Sex
ALL
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 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 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
* 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
Primary outcome measure(s)
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in DLT observation period — up to 24 weeks The safety and tolerability of WX390 will be evaluated based on adverse events data. Other safety parameters include physical examination, clinical laboratory tests including coagulation function, renal function, hepatic function, blood glucose and blood lipid, etc.
Progression-free survival rate (PFS rate) — up to 24 weeks PFS rate: is defined as the proportion of patients without objective tumor progression or death.
Objective response rate (ORR) — up to 24 weeks ORR: is defined as the proportion of patients with complete response (CR) and partial response (PR) according to RECIST 1.1.
Trial sites (1)
Facility
City
Region
Status
the first affiliated hospital of Jilin university
Changchun
Jilin
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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