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NOT YET RECRUITING
NCT07363330
PHASE2

A Phase II Study of Utidelone With Toripalimab in Advanced Cervical Cancer

Sponsor: Zhongnan Hospital

View on ClinicalTrials.gov

Summary

This is a Phase II clinical trial to evaluate the safety and efficacy of Utidelone, a genetically engineered epothilone derivative, combined with Toripalimab, a PD-1 inhibitor, in patients with recurrent or metastatic cervical cancer who have progressed after standard treatments. The study will also assess the safety profile of this combination therapy. The primary objectives of this study include: (1) to determine the objective response rate (ORR), meaning whether the treatment can reduce the size of tumors or make them disappear, according to the RECIST 1.1 criteria; (2) to evaluate the safety of the treatment and document the side effects experienced by participants. This study is for individuals who: (1) are between 18 and 75 years old; (2) have a confirmed diagnosis of recurrent or metastatic cervical cancer; (3) have previously received at least one standard chemotherapy regimen that is no longer controlling the cancer; (4) are in generally good health, as determined by the study investigators. In this single-arm study, all participants will receive the same treatment: Utidelone will be administered by intravenous (IV) infusion over 1.5 hours, once a day for 5 consecutive days, in each 21-day treatment cycle; Toripalimab will be administered by IV infusion over 1.5 hours, once on Day 6 of each 21-day cycle. Participants may continue receiving the study drugs as long as they are benefiting from the treatment and side effects are manageable. Doctors will assess tumor size using imaging scans (like CT or MRI) every 6 weeks to monitor how the cancer responds to treatment. The study will take place at Zhongnan Hospital of Wuhan University and plans to include approximately 32 participants.

Official title: Utidelone Combined With Toripalimab in Patients With Pretreated Recurrent or Metastatic Cervical Cancers: a Single-Arm, Phase II Study

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-02-01

Completion Date

2028-12-31

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DRUG

Utidelone plus Toripalimab

1. Drug: Utidelone (1)Dosage: 30 mg/m² (2)Route of Administration: Intravenous drip (IV infusion) (3)Schedule: Administered once daily on Days 1-5 of each cycle. (4)Cycle Duration: 21 days (q3w). 2. Drug: Toripalimab (1)Dosage: 240 mg (2)Route of Administration: Intravenous drip (IV infusion) (3)Schedule: Administered on Day 6 of each cycle. (4)Cycle Duration: 21 days (q3w).

Locations (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China