A Study of WX390 in Patients With Advanced Solid Tumors

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

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.

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.

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