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NCT Number: NCT06117540

A Study 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.

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Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Xiaohua Wu, PhD

CONTACT

Xiaohua Wu, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WX390

Drug

WX390 tablet, 1.1 mg once a day

Other names: WXFL10030390

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Week 48

    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.

  2. Overall Survival (OS)

    Time frame: Week 48

    OS, time from first dose of trial medication to death due to any cause.

  3. Duration of Response (DOR)

    Time frame: Week 48

    DoR, the time from the first occurrence of objective response until disease progression or death from any cause, whichever occurs first.

  4. Progression-free survival rate (PFSR)

    Time frame: Week 24 and Week 48

    PFSR, Percentage of patients alive without progression from baseline.

  5. Objective Response Rate (ORR)

    Time frame: Week 24 and Week 48

    ORR, proportion of patients with complete response (CR) or partial response (PR).

  6. Disease control rate (DCR)

    Time frame: Week 24 and Week 48

    DCR, proportion of patients with CR or PR or SD.

Secondary outcomes

  1. Incidence, nature, and severity of adverse events (AEs)

    Time frame: Week 24 and Week 48

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajia Li

CONTACT

[email protected]

008621-64175590

Sponsors and collaborators

Lead sponsor

Shanghai Jiatan Pharmatech Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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