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RECRUITING
NCT07902999
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

HB0025 Injection

20mg/kg, ivgtt, Q3W, developed by Sponsor Huaota

DRUG

Paclitaxel injection

175mg/m\^2, Q3W

DRUG

Carboplatin injection

AUC5, Q3W

OTHER

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