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Recruiting NCT06124963

A Study of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations

Phase II Interventional Gastric Type Adenocarcinoma (GAS) With STK11 Mutation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WX390, Toripalimab.
Who it may be relevant to
Registry conditions: Gastric Type Adenocarcinoma (GAS) With STK11 Mutation. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Gastric-type Endocervical Adenocarcinoma With STK11 Mutations

Overview

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.

Detailed description

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 28-days screening period to determine eligibility for study entry. And then patents will be administered for 8 cycles treatment and 8 weeks safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.

Interventions

  • Drug WX390
    WX390 tablet, 0.9 mg once a day
  • Drug Toripalimab
    240 mg, Day 1, every 3 weeks

Primary outcome measures

  • Progression-free survival rate (PFS rate) [Time frame: up to 24 weeks]
  • Objective response rate (ORR) [Time frame: up to 24 weeks]
Secondary outcome measures (3)
  • Progression-free survival (PFS) [Time frame: up to 24 weeks]
  • Overall survival (OS) [Time frame: up to 48 weeks]
  • Time to reach plasma Cmax (Tmax) of WX390 [Time frame: up to 24 weeks]

Eligibility criteria

Inclusion criteria

  • ≥18 years of age
  • Histological or cytological confirmed advanced Gastric-type Endocervical Adenocarcinoma.
  • 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 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
  • Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose 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
  • History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection
  • Inability to take medication orally
  • Abuse of alcohol or drugs
  • People with cognitive and psychological abnormality or with low compliance
  • Pregnant or lactating women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hosp — Shanghai

Identifiers

NCT: NCT06124963 · JYP0390M207

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗