A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors
NCT ID: NCT06117566
Last Updated: 2024-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2022-11-18
2025-11-09
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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WX390 0.5 mg + Toripalimab 240mg
Participants will receive WX390 continuous oral dosing (0.5 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
WX390
WX390 tablet, once a day
Toripalimab
240 mg, Day 1, every 3 weeks
WX390 0.7 mg + Toripalimab 240mg
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
WX390 tablet, once a day
Toripalimab
240 mg, Day 1, every 3 weeks
WX390 0.9 mg + Toripalimab 240mg
Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).
WX390
WX390 tablet, once a day
Toripalimab
240 mg, Day 1, every 3 weeks
Interventions
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WX390
WX390 tablet, once a day
Toripalimab
240 mg, Day 1, every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Shanghai Jiatan Pharmatech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Yanhua Ding, PhD
Role: PRINCIPAL_INVESTIGATOR
the first affiliated hospital of Jilin university
Locations
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the first affiliated hospital of Jilin university
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Yanhua Ding, PhD
Role: primary
Other Identifiers
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JYP0390M203
Identifier Type: -
Identifier Source: org_study_id
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