A Study of WX390 in Patients With Advanced Solid Tumors

NCT06117540 | Recruiting Phase 2

• 1 other identifier: WX390-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Incidence, nature, and severity of adverse events (AEs)

  Week 24 and Week 48

Study Arms (1)

WX390

EXPERIMENTAL

Participants will receive WX390 continuous oral dosing (1.1 mg once a day).

Drug: WX390

Interventions

WX390 DRUG

WX390 tablet, 1.1 mg once a day

Also known as: WXFL10030390

WX390

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• 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
• 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
• 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

Sponsors & Collaborators

• Shanghai Jiatan Pharmatech Co., Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Officials

• Xiaohua Wu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiajia Li

CONTACT

008621-64175590; doc_lijiajia@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 7, 2023
• Study Start: May 11, 2021
• Primary Completion: June 12, 2025
• Study Completion (Estimated): June 12, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-10

Locations

CN (1)