A Study of WX390 in Patients With Advanced Solid Tumors

Shanghai Jiatan Pharmatech

Status and phase

Enrolling

Phase 2

Conditions

Solid Tumor

Treatments

Drug: WX390

Study type

Interventional

Funder types

Industry

Identifiers

NCT06117540

WX390-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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