A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Recurrent or Metastatic Cervical Cancer

Treatments: Drug: SHR-A1811 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07051486

SHR-A1811-218

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

SHR-A1811 Group

Experimental group

Treatment:

Drug: SHR-A1811 Injection