A Phase 3 interventional study of HB0025 Injection and Paclitaxel injection in First-line pMMR Endometrial Cancer, sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd.. Recruiting at 2 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Shanghai Huaota Biopharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 333 is above the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Shanghai Huaota Biopharmaceutical Co., Ltd. is the lead sponsor of 19 studies on the registry; 14 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HB0025 combined with Paclitaxel for Injection plus Carboplatin for Injection
Drug: HB0025 Injection · Drug: Paclitaxel injection · Drug: Carboplatin injection
Placebo combined with Paclitaxel for Injection plus Carboplatin for Injection
Drug: Paclitaxel injection · Drug: Carboplatin injection · Other: Placebo matching HB0025
20mg/kg, ivgtt, Q3W, developed by Sponsor Huaota
175mg/m\^2, Q3W
AUC5, Q3W
Participants will be administered placebo matching HB0025
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the Blinded Independent Central Review or death due to any cause (whichever occurs first)
Time frame: Up to 34 months
Progression-free survival (PFS)
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first)
Time frame: Up to 34 months
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects achieving the best overall response (BOR) as complete response (CR) or partial response (PR) according to RECIST 1.1 by investigator or Blinded Independent Central Review.
Time frame: Up to 34 months
Disease control rate (DCR)
DCR defined as the number of patients were confirmed CR or PR or stable disease(SD) according to RECIST 1.1 by investigator or Blinded Independent Central Review divided by the patients with at least one tumour evaluation.
Time frame: Up to 34 months
Duration of response (DOR)
DOR is defined as the time from the first record of CR or PR to the first record of disease progression as evaluated by investigators or Blinded Independent Central Review according to RECIST v1.1 or death.
Time frame: Up to 34 months
Time to Progression(TTP)
TTP is defined as the time from the time of randomization to the occurrence of disease progression according to Recist 1.1 by investigator or Blinded Independent Central Review.
Time frame: Up to 34 months
Overall Survival (OS)
OS is defined as the period from the start of randomization to the time of death due to any cause.
Time frame: Up to 34 months
Safety Assessment
The incidence, severity and outcome of adverse events (AE), serious adverse events (SAE), immune-related adverse events (irAE) and adverse events of special interest (AESI) per NCI-CTCAE V6.0.
Time frame: Up to 34 months
Cmax
Peak Plasma Concentration
Time frame: Up to 34 months
AUC
Area under the plasma concentration versus time curve
Time frame: Up to 34 months
ADA titer
titer of anti-drug antibody
Time frame: Up to 34 months
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Sotiburafusp alfa
Shanghai Huaota Biopharmaceutical Co., Ltd.