NCT07051486 A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
| NCT ID | NCT07051486 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Condition | Recurrent or Metastatic Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-11 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-10-11 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a single-arm, multicenter Phase II clinical trial of SHR-A1811 for injection in patients with HER2-expressing recurrent or metastatic cervical cancer who have failed prior systemic therapy.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up. 2. Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent). 3. Cervical cancer confirmed by tissue or cytological pathology. 4. Expected survival ≥ 12 weeks. 5. Normal function of important organs. 6. Female subjects of fertility must have a negative serum HCG test within 7 days before the first dose of Investigational Medicinal Product (IMP), and must not be breastfeeding, and must agree to comply with contraceptive requirements from the signing of the informed consent until the last dose of the trial drug for 7 months. Exclusion Criteria: 1. Subjects with known untreated or active central nervous system (CNS) tumor metastases. 2. Subjects with other malignant tumors in the past or at the same time. 3. Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion. 4. Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment. 5. Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs. 6. Subjects with known lung damage caused by concurrent lung diseases. 7. Subjects with active pulmonary tuberculosis. 8. Subjects with poorly controlled or severe cardiovascular diseases. 9. Subjects with arterial/venous thrombotic events within 1 month before enrollment. 10. Subjects who had a serious infection within 1 month before enrollment. 11. History of immunodeficiency, including positive HIV test.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07051486 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Recurrent or Metastatic Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07051486 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07051486 currently recruiting?
Yes, NCT07051486 is actively recruiting participants. Contact the research team at na.an@hengrui.com for enrollment information.
Where is the NCT07051486 trial being conducted?
This trial is being conducted at Fuzhou, China, Jinan, China.
Who is sponsoring the NCT07051486 clinical trial?
NCT07051486 is sponsored by Jiangsu HengRui Medicine Co., Ltd.. The trial plans to enroll 60 participants.
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