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HB0025-C-0301: A Study to Investigate HB0025 Combined With Chemotherapy as First-Line Treatment for Advanced or Recurrent MMR-proficient Endometrial Cancer
Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
Summary
This is a multicenter, randomized, double-blind, placebo controlled Phase III clinical trial, aiming to evaluate the efficacy and safety of HB0025 combined with chemotherapy (paclitaxel plus carboplatin) versus placebo combined with chemotherapy (paclitaxel plus carboplatin) as a first-line treatment for advanced (Stage III/IV) or recurrent proficient Mismatch Repair Endometrial Cancer(pMMR EC). The trial will take progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) as the primary endpoint, and plans to enroll approximately 333 participants. After being eligible for screening, participants will be randomly assigned to the study arms at a ratio of 2:1 to receive either HB0025 combined with chemotherapy (experimental group) or placebo combined with chemotherapy (control group). Both regimens will be administered once every 3 weeks (Q3W). After completing 6 cycles of combination treatment, patients will enter the maintenance therapy phase with HB0025 or placebo (Q3W) only. The treatment will last until intolerable toxicity occurs, disease progression, lost to follow up or death, withdrawal of consent, pre-scheduled study treatment are completed, receiving new anticancer therapy or sponsor discontinue the study, whichever comes first.
Official title: A Randomized, Double-Blind, Multicenter Phase III Clinical Trial of HB0025 Injection Combined With Chemotherapy Versus Placebo Combined With Chemotherapy as First-Line Treatment for Advanced or Recurrent Endometrial Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
333
Start Date
2026-10-20
Completion Date
2031-06-26
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
HB0025 Injection
20mg/kg, ivgtt, Q3W, developed by Sponsor Huaota
Paclitaxel injection
175mg/m\^2, Q3W
Carboplatin injection
AUC5, Q3W
Placebo matching HB0025
Participants will be administered placebo matching HB0025
Locations (2)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China