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

Solid Tumor Clinical Trial

Official title:

A Phase Ib/IIa Study to Evaluate the Safety and Preliminary Efficacy of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117566
• Other study ID #: JYP0390M203
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 18, 2022
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Shanghai Jiatan Pharmatech Co., Ltd
• Contact: Xiaoxue Zhu
• Phone: 0086431-88782222
• Email: 123999320[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will be an open-label, multicenter phase Ib/IIa clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =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

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
China	the first affiliated hospital of Jilin university	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiatan Pharmatech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Progression-free survival (PFS)	PFS: is defined as the time from randomization until objective tumor progression or death, whichever occurs first.	up to 48 weeks
Secondary	Overall survival (OS)	OS: is defined as the time from randomization until death from any cause.	up to 48 weeks
Secondary	Disease-control rate (DCR)	DCR: is defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD) according to RECIST 1.1.	up to 24 weeks