The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 in patients with advanced solid tumors. The main question it aims to answer is: • safety and preliminary efficacy in WX390 therapy. Participants will be treated with WX390 orally and follow the efficacy and safety evaluation according to the protocol.
This study is a multicenter, open-label phase Ib/IIa clinical trial for patients with advanced solid tumors who have failed standard treatment. The study adopts a basket design, divided into 6 cohorts, with a total of 70-80 advanced solid tumor patients with PIK3CA mutations enrolled. Participants will receive WX390 treatment administered continuously daily, with each cycle lasting 28 days, until disease progression or intolerable toxicity occurs. During the study, safety and efficacy will be evaluated, with efficacy assessment based on RECIST 1.1. In addition, the study will collect tumor tissue or blood samples from the participants to explore the relationship between other biomarkers and treatment efficacy, as well as the impact of changes in PIK3CA mutation status before and after treatment on efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Participants will receive WX390 1.1 mg tablet orally once a day for a continuous 28-day cycle.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Safety of WX390 in treating patients with advanced malignant solid tumors harboring PIK3CA mutations.
Safety will be evaluated by monitoring AE/SAE
Time frame: From the start of the trial,up to 24 weeks
Objective Response Rate (ORR)
ORR is defined as the proportion of patients with complete response (CR) and partial response (PR) according to RECIST 1.1.
Time frame: From the start of the trial,up to 24 weeks
Disease Control Rate (DCR) determined according to RECIST 1.1 criteria
DCR is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD) according to RECIST 1.1.
Time frame: From the start of the trial,up to 24 weeks
Duration of Response (DOR) determined according to RECIST 1.1 criteria
DOR is defined as the time from the initial occurrence of a complete response (CR) or partial response (PR) until disease progression or death due to any cause.
Time frame: From the start of the trial,up to 24 weeks
Progression-Free Survival (PFS) determined according to RECIST 1.1 criteria
PFS is defined as the time from randomization until objective tumor progression or death, whichever occurs first.
Time frame: From the start of the trial,up to 24 weeks
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