A Study of WX390 in Patients With Advanced Solid Tumors
NCT ID: NCT06117540
Last Updated: 2024-11-19
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
PHASE2
70 participants
INTERVENTIONAL
2021-05-11
2026-06-12
Brief Summary
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* PFS, OS, DoR at week 48;
* antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, 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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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WX390
Participants will receive WX390 continuous oral dosing (1.1 mg once a day).
WX390
WX390 tablet, 1.1 mg once a day
Interventions
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WX390
WX390 tablet, 1.1 mg once a day
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
* 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
* 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
* Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
* Active hepatitis B or C infection
* Inability to take medication orally
* Abuse of alcohol or drugs
* Pregnant or lactating women
* People with cognitive and psychological abnormality or with low compliance
18 Years
FEMALE
No
Sponsors
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Shanghai Jiatan Pharmatech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaohua Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xiaohua Wu, PhD
Role: primary
Other Identifiers
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WX390-002
Identifier Type: -
Identifier Source: org_study_id
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