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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: WX390; Drug: Toripalimab

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoxue Zhu; Phone Number: 0086431-88782222; Email: 123999320@qq.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The First Affiliated Hospital of Jilin University
      • Principal Investigator: Yanhua Ding, PhD
      • Contact: Yanhua Ding, 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WX390 0.5 mg + Toripalimab 240mg; 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; WX390 tablet, once a day; Other Names: WXFL10030390; Drug: Toripalimab; 240 mg, Day 1, every 3 weeks
Experimental: WX390 0.7 mg + Toripalimab 240mg; 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; WX390 tablet, once a day; Other Names: WXFL10030390; Drug: Toripalimab; 240 mg, Day 1, every 3 weeks
Experimental: WX390 0.9 mg + Toripalimab 240mg; 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; WX390 tablet, once a day; Other Names: WXFL10030390; Drug: Toripalimab; 240 mg, Day 1, every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall survival (OS)	OS: is defined as the time from randomization until death from any cause.	up to 48 weeks
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

Collaborators and Investigators

• Sponsor: Shanghai Jiatan Pharmatech Co., Ltd
• Investigators: Principal Investigator: Yanhua Ding, PhD, The First Affiliated Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: JYP0390M203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No