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

November 3, 2023 updated by: Shanghai Jiatan Pharmatech Co., Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200090
        • Recruiting
        • The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)
        • Contact:
          • Yu Kang, PhD
        • Principal Investigator:
          • Yu Kang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WX390 + Toripalimab
Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240 mg, intravenous, Day 1, every 3 weeks).
Drug: Toripalimab
240 mg, Day 1, every 3 weeks
Drug: WX390
WX390 tablet, 0.9 mg once a day
Other Names:
  • WXFL10030390

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival rate (PFS rate)
Time Frame: up to 24 weeks
PFS rate, defined as the proportion of patients who have not experienced disease progression (PD) or death due to any cause during the study period.
up to 24 weeks
Objective response rate (ORR)
Time Frame: up to 24 weeks
ORR, defined as the percentage of participants with complete response (CR) or partial response (PR) confirmed by RECIST v1.1 assessment.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: up to 24 weeks
PFS, defined as the time from the first treatment to the first occurrence of disease progression or death due to any cause during the study period (whichever comes first).
up to 24 weeks
Overall survival (OS)
Time Frame: up to 48 weeks
OS, defined as the time from the first treatment to death due to any cause.
up to 48 weeks
Time to reach plasma Cmax (Tmax) of WX390
Time Frame: up to 24 weeks
Test the plasma drug concentration of WX390 to calculate Tmax.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiatan Pharmatech Co., Ltd

Investigators

  • Principal Investigator: Yu Kang, PhD, The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Estimated)

November 9, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JYP0390M207

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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