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

NCT06124963 | Recruiting Phase 2

• 1 other identifier: JYP0390M207
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Progression-free survival (PFS)

  up to 24 weeks

• Overall survival (OS)

  up to 48 weeks

• Time to reach plasma Cmax (Tmax) of WX390

  up to 24 weeks

Study Arms (1)

WX390 + Toripalimab

EXPERIMENTAL

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: WX390; Drug: Toripalimab

Interventions

WX390 DRUG

WX390 tablet, 0.9 mg once a day

Also known as: WXFL10030390

WX390 + Toripalimab

Toripalimab DRUG

240 mg, Day 1, every 3 weeks

WX390 + Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiatan Pharmatech Co., Ltd: lead

Study Sites (1)

The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)

Shanghai, Shanghai Municipality, 200090, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• Yu Kang, PhD

  The Obstetrics & Gynecology Hospital of Fudan University (Shanghai Red House Ob & Gyn Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaoli He

CONTACT

008621-63453967; fcklcsyjg@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: WX390 continuous oral dosing (0.9 mg once a day) Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks)

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 9, 2023
• Study Start: August 25, 2023
• Primary Completion: December 12, 2025
• Study Completion (Estimated): December 9, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-11

Locations

CN (1)