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

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: Gastric Type Adenocarcinoma (GAS) With STK11 Mutation
• Intervention / Treatment: Drug: Toripalimab; Drug: WX390

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

• Study Contact: Name: Gaoli He; Phone Number: 008621-63453967; Email: fcklcsyjg@163.com

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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)	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)	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)	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)	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	Test the plasma drug concentration of WX390 to calculate Tmax.	up to 24 weeks

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): December 12, 2025
• Study Completion (Estimated): December 9, 2026

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• 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