NCT07392060

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

A Randomized, Open-Label, Controlled, Multicenter 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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Shanghai Jiatan Pharmatech Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-02-28
• Primary completion: 2029-09-30
• Completion: 2030-06-30
• First posted: 2026-02-06
• Last updated: 2026-02-06