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A Study of WX390 in Patients With Advanced Solid Tumors

S

Shanghai Jiatan Pharmatech

Status and phase

Enrolling
Phase 2

Conditions

Solid Tumor

Treatments

Drug: WX390

Study type

Interventional

Funder types

Industry

Identifiers

NCT06117540
WX390-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

WX390
Experimental group
Description:
Participants will receive WX390 continuous oral dosing (1.1 mg once a day).
Treatment:
Drug: WX390

Trial contacts and locations

1

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Central trial contact

Jiajia Li

Data sourced from clinicaltrials.gov

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