A Study of WX390 in Patients With Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorShanghai Jiatan Pharmatech Co., Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
WX390
DrugWX390 tablet, 1.1 mg once a day
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: WX390Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
PFS, time from the first dose of trial medication to the first occurrence of disease progression or death due to any cause on study, whichever occurs first.
Time frame
Week 482
Overall Survival (OS)
OS, time from first dose of trial medication to death due to any cause.
Time frame
Week 483
Duration of Response (DOR)
DoR, the time from the first occurrence of objective response until disease progression or death from any cause, whichever occurs first.
Time frame
Week 484
Progression-free survival rate (PFSR)
PFSR, Percentage of patients alive without progression from baseline.
Time frame
Week 24 and Week 48Secondary outcomes
1
Incidence, nature, and severity of adverse events (AEs)
Incidence, nature, and severity of adverse events (AEs) refer to the frequency, type, and level of harm of undesirable effects in clinical trials. Incidence shows how often AEs occur. Nature describes the specific characteristics of AEs, while severity indicates the extent of harm caused.
Time frame
Week 24 and Week 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov