A Study of WX390 in Patients With Advanced Solid Tumors

NCT ID: NCT06117540

Last Updated: 2024-11-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-11

Study Completion Date

2026-06-12

Brief Summary

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The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are:

* 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.

Detailed Description

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This study will be an open-label, multicenter phase II 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 12 cycles treatment and 30 days safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WX390

Participants will receive WX390 continuous oral dosing (1.1 mg once a day).

Group Type EXPERIMENTAL

WX390

Intervention Type DRUG

WX390 tablet, 1.1 mg once a day

Interventions

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WX390

WX390 tablet, 1.1 mg once a day

Intervention Type DRUG

Other Intervention Names

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WXFL10030390

Eligibility Criteria

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Inclusion Criteria

* ≥18 years of age
* 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

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiatan Pharmatech Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiajia Li

Role: CONTACT

008621-64175590

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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