A Study of WX390 in Patients With Advanced Solid Tumors

An Open-label, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of WX390 in Patients With Advanced Solid Tumors

The goal of this clinical trial is to evaluate the efficacy and safety of WX390 in patients with advanced solid tumors. The main questions it aims to answer are:

• PFS, OS, DoR at week 48;
• antitumor effects at week 24 and week 48. Participants will be treated with WX390 orally, and follow the efficacy and safety evaluation according to the protocol.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: 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 4-week screening period to determine eligibility for study entry. And then patents will be administered for 12 cycles treatment and 30 days 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): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jiajia Li; Phone Number: 008621-64175590; Email: doc_lijiajia@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Xiaohua Wu, PhD
      • Principal Investigator: Xiaohua Wu, 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
• 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
• 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
• Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
• Active hepatitis B or C infection
• Inability to take medication orally
• Abuse of alcohol or drugs
• Pregnant or lactating women
• People with cognitive and psychological abnormality or with low compliance

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WX390; Participants will receive WX390 continuous oral dosing (1.1 mg once a day).	Drug: WX390; WX390 tablet, 1.1 mg once a day; Other Names: WXFL10030390

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS, time from the first dose of trial medication to the first occurrence of disease progression or death due to any cause on study, whichever occurs first.	Week 48
Overall Survival (OS)	OS, time from first dose of trial medication to death due to any cause.	Week 48
Duration of Response (DOR)	DoR, the time from the first occurrence of objective response until disease progression or death from any cause, whichever occurs first.	Week 48
Progression-free survival rate (PFSR)	PFSR, Percentage of patients alive without progression from baseline.	Week 24 and Week 48
Objective Response Rate (ORR)	ORR, proportion of patients with complete response (CR) or partial response (PR).	Week 24 and Week 48
Disease control rate (DCR)	DCR, proportion of patients with CR or PR or SD.	Week 24 and Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, nature, and severity of adverse events (AEs)	Incidence, nature, and severity of adverse events (AEs) refer to the frequency, type, and level of harm of undesirable effects in clinical trials. Incidence shows how often AEs occur. Nature describes the specific characteristics of AEs, while severity indicates the extent of harm caused.	Week 24 and Week 48

Collaborators and Investigators

• Sponsor: Shanghai Jiatan Pharmatech Co., Ltd
• Investigators: Principal Investigator: Xiaohua Wu, PHD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 2, 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 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: WX390-002

Drug and device information, study documents

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