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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WX390 0.5 mg + Toripalimab 240mg | Experimental | Participants will receive WX390 continuous oral dosing (0.5 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks). |
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| WX390 0.7 mg + Toripalimab 240mg | Experimental | Participants will receive WX390 continuous oral dosing (0.7 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks). |
|
| WX390 0.9 mg + Toripalimab 240mg | Experimental | Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WX390 | Drug | WX390 tablet, once a day |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoxue Zhu | Contact | 0086431-88782222 | 123999320@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding, PhD | the first affiliated hospital of Jilin university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first affiliated hospital of Jilin university | Recruiting | Changchun | Jilin | 130000 | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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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)
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| Toripalimab | Drug | 240 mg, Day 1, every 3 weeks |
|
| 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 |