A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations
NCT06124963 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-12-10
Summary
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced Gastric-type Endocervical Adenocarcinoma with STK11 mutations. The main questions it aims to answer are:
* Pharmacokinetic (PK) characteristics of WX390 combined with Toripalimab treatment.
* Safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.
Conditions
- Gastric Type Adenocarcinoma (GAS) With STK11 Mutation
Interventions
- DRUG
-
WX390
WX390 tablet, 0.9 mg once a day
- DRUG
-
Toripalimab
240 mg, Day 1, every 3 weeks
Sponsors & Collaborators
-
Shanghai Jiatan Pharmatech Co., Ltd
lead INDUSTRY
Principal Investigators
-
Yu Kang, PhD · The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-25
- Primary Completion
- 2025-12-12
- Completion
- 2026-12-09
Countries
- China
Study Locations
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