NCT07902999RecruitingPhase 3
HB0025-C-0301: A Study to Investigate HB0025 Combined With Chemotherapy as First-Line Treatment for Advanced or Recurrent MMR-proficient Endometrial Cancer
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 333 (estimated)
- First submitted
- 20 Oct 2026
- Start date
- 20 Oct 2026
- Primary completion date
- 23 Apr 2029
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Diseases
- Endometrial cancer
- NCT number
- NCT07902999
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 333
- From 20 Oct 2026 to the primary completion date, 23 Apr 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Second primary malignancy within 5 years before screening.
- 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.
- Known psychiatric disorder, alcoholism, drug addiction or substance abuse.
Other
- Brain metastases accompanied by central nervous system symptoms.
- Pregnant or lactating women.
- Participant who, in the opinion of the investigator, are unsuitable to participate in this trial for any other reason.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.