Status:
COMPLETED
A Study of WX390 in Patients With Advanced Solid Tumors With PIK3CA Mutations
Lead Sponsor:
Shanghai Jiatan Pharmatech Co., Ltd
Conditions:
PIK3CA Mutation-Related Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ef...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 18-75 years of age
- Histologically or cytologically confirmed advanced malignant solid tumors (excluding non-small cell lung cancer) who have failed standard treatment, have no standard treatment options, or for whom standard treatment is not suitable at the current stage (colorectal cancer patients must provide genetic test results confirming KRAS wild-type)
- 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 organic function
- Signed and dated informed consent
Exclusion
- Anti-tumor treatments such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy received within 4 weeks before the first use of the study drug
- Other unapproved clinical trial drugs or treatments received within 4 weeks before the first use of the study drug
- Major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first use of the study drug
- Systemic use of corticosteroids or other immunosuppressive agents within 14 days before the first use of the study drug
- Previous treatment with PI3K, AKT, or mTOR inhibitors
- Active infection requiring systemic anti-infection treatment
- Known alcohol or drug dependence
- Individuals with mental disorders or poor compliance
- Pregnant or lactating women
- The researcher believes that the subject has other serious systemic medical history or other reasons that make them unsuitable for participating in this clinical study
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06132932
Start Date
June 3 2021
End Date
January 3 2023
Last Update
November 15 2023
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 310000