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

Sponsor
Zhongnan Hospital
Study ID
NCT07363330
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Utidelone plus Toripalimab — DRUG
    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).

Study Details

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.

Key Dates

First listed
Jan 23, 2026
Start date
Feb 1, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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).

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Tumor assessments are performed at baseline and every 6 weeks (± 3 days) until progression or start of new therapy. ORR is analyzed after all patients have completed at least 18 weeks of follow-up or experienced a study endpoint event. ]

Central Contacts

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