A Study of WX390 in Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06117540
• Other study ID #: WX390-002
• Status: Recruiting
• Phase: Phase 2
• Start date: May 11, 2021
• Est. completion date: June 2024

Study information

• Verified date: October 2023
• Source: Shanghai Jiatan Pharmatech Co., Ltd
• Contact: Jiajia Li
• Phone: 008621-64175590
• Email: doc_lijiajia[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• WX390
WX390 tablet, 1.1 mg once a day

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

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	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
Primary	Overall Survival (OS)	OS, time from first dose of trial medication to death due to any cause.	Week 48
Primary	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
Primary	Progression-free survival rate (PFSR)	PFSR, Percentage of patients alive without progression from baseline.	Week 24 and Week 48
Primary	Objective Response Rate (ORR)	ORR, proportion of patients with complete response (CR) or partial response (PR).	Week 24 and Week 48
Primary	Disease control rate (DCR)	DCR, proportion of patients with CR or PR or SD.	Week 24 and Week 48
Secondary	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