Trials / Completed
CompletedNCT06132932
A Study of WX390 in Patients With Advanced Solid Tumors With PIK3CA Mutations
A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390, a PI3K/mTOR Dual Inhibitor, for the Treatment of Advanced Solid Tumors With PIK3CA Mutations
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Shanghai Jiatan Pharmatech Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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 efficacy in WX390 therapy. Participants will be treated with WX390 orally and follow the efficacy and safety evaluation according to the protocol.
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, 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WX390 | Participants will receive WX390 1.1 mg tablet orally once a day for a continuous 28-day cycle. |
Timeline
- Start date
- 2021-06-03
- Primary completion
- 2023-01-03
- Completion
- 2023-01-03
- First posted
- 2023-11-15
- Last updated
- 2023-11-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06132932. Inclusion in this directory is not an endorsement.