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A Study of WX390 in Patients With Advanced Solid Tumors

Sponsor
Shanghai Jiatan Pharmatech Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06117540
Collaborator
(none)
70
Enrollment
1
Location
1
Arm
36.7
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 11, 2021
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) [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) [Week 48]

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

    3. Duration of Response (DOR) [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) [Week 24 and Week 48]

      PFSR, Percentage of patients alive without progression from baseline.

    5. Objective Response Rate (ORR) [Week 24 and Week 48]

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

    6. Disease control rate (DCR) [Week 24 and Week 48]

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

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200000

    Sponsors and Collaborators

    • Shanghai Jiatan Pharmatech Co., Ltd

    Investigators

    • Principal Investigator: Xiaohua Wu, PhD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Jiatan Pharmatech Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT06117540
    Other Study ID Numbers:
    • WX390-002
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Nov 7, 2023