A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: WX390
* Drug: Toripalimab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WX390 0.5 mg + Toripalimab 240mg<br>Participants will receive WX390 continuous oral dosing (0.5 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks). | Drug: WX390<br>* WX390 tablet, once a day<br>* Other names: WXFL10030390;Drug: Toripalimab<br>* 240 mg, Day 1, every 3 weeks<br>|
| Experimental: WX390 0.7 mg + Toripalimab 240mg<br>Participants will receive WX390 continuous oral dosing (0.7 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks). | Drug: WX390<br>* WX390 tablet, once a day<br>* Other names: WXFL10030390;Drug: Toripalimab<br>* 240 mg, Day 1, every 3 weeks<br>|
| Experimental: WX390 0.9 mg + Toripalimab 240mg<br>Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks). | Drug: WX390<br>* WX390 tablet, once a day<br>* Other names: WXFL10030390;Drug: Toripalimab<br>* 240 mg, Day 1, every 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in DLT observation period | 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. | up to 24 weeks | 
| Progression-free survival rate (PFS rate) | PFS rate: is defined as the proportion of patients without objective tumor progression or death. | up to 24 weeks | 
| Objective response rate (ORR) | ORR: is defined as the proportion of patients with complete response (CR) and partial response (PR) according to RECIST 1.1. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | PFS: is defined as the time from randomization until objective tumor progression or death, whichever occurs first. | up to 48 weeks | 
| Overall survival (OS) | OS: is defined as the time from randomization until death from any cause. | up to 48 weeks | 
| Disease-control rate (DCR) | DCR: is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD) according to RECIST 1.1. | up to 24 weeks |