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First-line pMMR Endometrial CancerPhase 3NCT07902999

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

A Phase 3 study testing HB0025 Injection, Paclitaxel injection and Carboplatin injection in people with First-line pMMR Endometrial Cancer, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
First-line pMMR Endometrial Cancer
What is being tested?
HB0025 Injection, Paclitaxel injection and Carboplatin injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
333 participants
Where
2 sitesChina
Study dates
20 Oct 2026to 26 Jun 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients aged 18 years or older at screening.
  • Able to fully understand and voluntarily sign the informed consent form, and are willing and able to follow the clinical trial and subsequent visit procedures.
  • Patients diagnosed with advanced (stage III/IV, classified according to the 2009 International Federation of Gynecology and Obstetrics (FIGO)) or recurrent endometrial cancer, whose pathological type include but are not limited to endometrial adenocarcinoma, serous carcinoma, clear cell carcinoma, undifferentiated carcinoma, dedifferentiated carcinoma, mixed carcinoma, carcinosarcoma (excluding uterine sarcoma), and confirmed as pMMR in the central laboratory.
  • Patients who had not received any systemic anti-tumor treatment for endometrial cancer in the past and are not suitable for radical surgical resection and/or radical concurrent radiotherapy.
  • Agree and can provide sufficient and qualified tumor tissue samples from the primary site or metastatic site (either archived tissue samples from the past 3 years before randomization or fresh tissue samples) for the detection of MMR and PD-L1 status.
  • ECOG PS of 0-1.
  • Adequate organ function.

Who cannot join

  • Second primary malignancy within 5 years before screening.
  • Brain metastases accompanied by central nervous system symptoms.
  • Previously treated with immune checkpoint inhibitors and/or anti-angiogenic drugs.
  • Those who underwent surgery within 4 weeks before the first treatment , or suffered from major traumatic injuries, or were judged by the researchers to have not fully recovered from previous surgeries, or were expected to require surgery during the study period.
  • Arterial hypertension that remains uncontrolled even after receiving standard treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
  • Those who have had or currently have interstitial lung disease, pneumoconiosis, drug-related pneumonia, or severely impaired lung function, which may interfere with the detection and management of suspected drug-related pulmonary toxicity.
Show all 9Show fewer
  • Pregnant or lactating women.
  • Known psychiatric disorder, alcoholism, drug addiction or substance abuse.
  • Participant who, in the opinion of the investigator, are unsuitable to participate in this trial for any other reason.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites, 2 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Jundong Li, MD, 020-87343227, lijd@sysucc.org.cn

    Jundong Li, MD

    Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Lingying Wu, MD, 010-87788996, wulingying@csco.org.cn

    Lingying Wu, MD

    Not yet recruiting

Other trials in China

About this study

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

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.

Being tested
HB0025 Injection, Paclitaxel injection, Carboplatin injection, Placebo matching HB0025

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HB0025 InjectionDrug

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

  • Paclitaxel injectionDrug

    175mg/m^2, Q3W

  • Carboplatin injectionDrug

    AUC5, Q3W

  • Placebo matching HB0025Other

    Participants will be administered placebo matching HB0025

Study groups in NCT07902999
Study groupRoleWhat they receive
HB0025ExperimentalHB0025 combined with Paclitaxel for Injection plus Carboplatin for Injection
Receives: Drug: HB0025 Injection; Drug: Paclitaxel injection; Drug: Carboplatin injection
PlaceboPlacebo comparatorPlacebo combined with Paclitaxel for Injection plus Carboplatin for Injection
Receives: Drug: Paclitaxel injection; Drug: Carboplatin injection; Other: Placebo matching HB0025

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Up to 34 months

Secondary outcomes (10)

  1. 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)

    Measured: Up to 34 months

  2. 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.

    Measured: Up to 34 months

  3. 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.

    Measured: Up to 34 months

  4. 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.

    Measured: Up to 34 months

  5. 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.

    Measured: Up to 34 months

  6. Overall Survival (OS)

    OS is defined as the period from the start of randomization to the time of death due to any cause.

    Measured: Up to 34 months

  7. 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.

    Measured: Up to 34 months

  8. Cmax

    Peak Plasma Concentration

    Measured: Up to 34 months

  9. AUC

    Area under the plasma concentration versus time curve

    Measured: Up to 34 months

  10. ADA titer

    titer of anti-drug antibody

    Measured: Up to 34 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start20 Oct 2026 (estimated)
  3. Primary completion23 Apr 2029 (estimated)
  4. Study completion26 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
333 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07902999
Sponsor's protocol ID
HB0025-C-0301
Status last verified
Oct 2026
First submitted
20 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HB0025 Injection, Paclitaxel injection and Carboplatin injection in people with First-line pMMR Endometrial Cancer, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to 34 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07902999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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