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Trial Title:
A Study of WX390 in Patients With Advanced Solid Tumors
NCT ID:
NCT06117540
Condition:
Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
WX390
Description:
WX390 tablet, 1.1 mg once a day
Arm group label:
WX390
Other name:
WXFL10030390
Summary:
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:
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Wu, PhD
Investigator:
Last name:
Xiaohua Wu, PhD
Email:
Principal Investigator
Start date:
May 11, 2021
Completion date:
June 2024
Lead sponsor:
Agency:
Shanghai Jiatan Pharmatech Co., Ltd
Agency class:
Industry
Source:
Shanghai Jiatan Pharmatech Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06117540
