NCT07902999

HB0025-C-0301: A Study to Investigate HB0025 Combined With Chemotherapy as First-Line Treatment for Advanced or Recurrent MMR-proficient Endometrial Cancer

StatusRecruiting

PhasePhase 3

SponsorShanghai Huaota Biopharmaceutical Co., Ltd.

Primary completionApr 23, 2029 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 28, 2026 Study First Submitted

Endpoints

Primary

Progression-free survival (PFS)

Timeframe: Up to 34 months

Secondary (10)

Progression-free survival (PFS)

Objective Response Rate (ORR)

Disease control rate (DCR)

Duration of response (DOR)

Time to Progression(TTP)

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Overall Survival (OS)

Safety Assessment

Cmax

AUC

ADA titer

Arms and interventions

HB0025Experimental

HB0025 combined with Paclitaxel for Injection plus Carboplatin for Injection

PlaceboPlacebo comparator

Placebo combined with Paclitaxel for Injection plus Carboplatin for Injection

Drugs: HB0025 Injection, Paclitaxel injection, Carboplatin injection

Other: Placebo matching HB0025

Sites

2 sites in 1 country

About this trial

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.

Trial details

Enrollment: 333 participants (estimated)
Started: Oct 20, 2026
Study completion: Jun 26, 2031 (estimated)
Eligibility: 18 and older, female only, no healthy volunteers
Design: Interventional, randomized, quadruple blind, treatment
Oversight: Data monitoring committee
Conditions: First-line pMMR Endometrial Cancer
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
First posted: Oct 29, 2026
Registry updated: Oct 29, 2026
Last verified: Oct 2026

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