Recruiting

An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors

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What is being tested

WX390

Drug
Who is being recruted

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2021
See protocol details

Summary

Principal SponsorShanghai Jiatan Pharmatech Co., Ltd
Study ContactJiajia Li
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 11, 2021

Actual date on which the first participant was enrolled.

This study is exploring a treatment for people with advanced solid tumors using a drug called WX390. Solid tumors can be challenging to treat, and new therapies are needed to improve outcomes for patients. The aim is to assess how well WX390 works and how safe it is for patients. By focusing on these aspects, the study hopes to find a beneficial treatment option for individuals dealing with these severe types of cancer. Participants in the study will first go through a 4-week screening period to ensure they qualify to take part. Once enrolled, they will receive treatment with WX390 over 12 cycles. After the final treatment, there will be a 30-day period to monitor their safety. Throughout the study, researchers will closely track the effectiveness and any side effects of the treatment during each cycle. This structured approach helps determine the drug's potential benefits and any risks involved.

Official TitleAn Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors
NCT06117540
Principal SponsorShanghai Jiatan Pharmatech Co., Ltd
Study ContactJiajia Li
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
≥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
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11 exclusion criteria prevent from participating
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fudan University Shanghai Cancer Center

Shanghai, ChinaOpen Fudan University Shanghai Cancer Center in Google Maps
Recruiting
One Study Center