A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors

NCT06117566 | Recruiting Phase 1

• 1 other identifier: JYP0390M203
• Study Type: interventional
• Target: 100
• 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 solid tumors. The main questions it aims to answer are:

• the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of WX390;
• 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

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in DLT observation period

  The safety and tolerability of WX390 will be evaluated based on adverse events data. Other safety parameters include physical examination, clinical laboratory tests including coagulation function, renal function, hepatic function, blood glucose and blood lipid, etc.

  up to 24 weeks

• Progression-free survival rate (PFS rate)

  PFS rate: is defined as the proportion of patients without objective tumor progression or death.

  up to 24 weeks

• Objective response rate (ORR)

  ORR: is defined as the proportion of patients with complete response (CR) and partial response (PR) according to RECIST 1.1.

  up to 24 weeks

Secondary Outcomes (3)

• Progression-free survival (PFS)

  up to 48 weeks

• Overall survival (OS)

  up to 48 weeks

• Disease-control rate (DCR)

  up to 24 weeks

Study Arms (3)

WX390 0.5 mg + Toripalimab 240mg

EXPERIMENTAL

Participants will receive WX390 continuous oral dosing (0.5 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).

Drug: WX390; Drug: Toripalimab

WX390 0.7 mg + Toripalimab 240mg

EXPERIMENTAL

Participants will receive WX390 continuous oral dosing (0.7 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).

Drug: WX390; Drug: Toripalimab

WX390 0.9 mg + Toripalimab 240mg

EXPERIMENTAL

Participants will receive WX390 continuous oral dosing (0.9 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).

Drug: WX390; Drug: Toripalimab

Interventions

WX390 DRUG

WX390 tablet, once a day

Also known as: WXFL10030390

WX390 0.5 mg + Toripalimab 240mg; WX390 0.7 mg + Toripalimab 240mg; WX390 0.9 mg + Toripalimab 240mg

Toripalimab DRUG

240 mg, Day 1, every 3 weeks

WX390 0.5 mg + Toripalimab 240mg; WX390 0.7 mg + Toripalimab 240mg; WX390 0.9 mg + Toripalimab 240mg

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age
• Histological or cytological confirmed advanced solid tumor, standard regimen failed or no standard regimen available
• 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 organ 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 first affiliated hospital of Jilin university

Changchun, Jilin, 130000, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• Yanhua Ding, PhD

  the first affiliated hospital of Jilin university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoxue Zhu

CONTACT

0086431-88782222; 123999320@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: WX390 continuous oral dosing (0.5 mg once a day) WX390 continuous oral dosing (0.7 mg once a day) 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 7, 2023
• Study Start: November 18, 2022
• Primary Completion: November 9, 2025
• Study Completion: November 9, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

CN (1)