Solid Tumor
Conditions
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: * 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.
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 screening period to determine eligibility for study entry. And then patents will be administered for 8 cycles treatment and 8 weeks safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.
Interventions
DRUGWX390
WX390 tablet, once a day
DRUGToripalimab
240 mg, Day 1, every 3 weeks
Sponsors
Shanghai Jiatan Pharmatech Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
WX390 continuous oral dosing (0.5 mg once a day) WX390 continuous oral dosing (0.7 mg once a day) WX390 continuous oral dosing (0.9 mg once a day) Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | up to 48 weeks | PFS: is defined as the time from randomization until objective tumor progression or death, whichever occurs first. |
| Overall survival (OS) | up to 48 weeks | OS: is defined as the time from randomization until death from any cause. |
| Disease-control rate (DCR) | up to 24 weeks | DCR: is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD) according to RECIST 1.1. |
Countries
China
Contacts
Primary ContactXiaoxue Zhu
Outcome results
None listed