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A Phase III Clinical Study of WX390 Combined With Toripalimab Versus Investigator's Choice of Therapy in Patients With Recurrent or Metastatic Cervical Cancer Who Have Failed Prior Platinum-Based Treatment

NCT07392060 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2026-02-06

No results posted yet for this study

Summary

This is a Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study to evaluate the efficacy of WX390 in combination with toripalimab versus investigator's choice of therapy in patients with recurrent or metastatic cervical cancer who have failed at least one prior platinum-based systemic therapy, as assessed by overall survival (OS).

Conditions

  • Cervical Cancer Metastatic

Interventions

DRUG

WX390 1.1mg + Toripalimab 240mg

Participants will receive WX390 continuous oral dosing (1.1 mg once a day) and Toripalimab fixed dose (240mg, intravenous, Day 1, every 3 weeks).

DRUG

Investigator's Choice of Chemotherapy

Randomization for these two strata will be closed upon reaching the total enrollment of 310 subjects who are immunotherapy-naïve or have tumors with PIK3CA wild-type status confirmed by the central laboratory.

Sponsors & Collaborators

  • Shanghai Jiatan Pharmatech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2029-09-30
Completion
2030-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07392060 on ClinicalTrials.gov