Recurrent or Metastatic Cervical Cancer
Conditions
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.
Interventions
SHR-A1811 for injection.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed by Independent Review Committee (IRC) | Up to 2 years. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response (DoR) assessed by investigators | Up to 2 years. |
| Disease control rate (DCR) assessed by Independent Review Committee (IRC) | Up to 2 years. |
| Disease control rate (DCR) assessed by investigators | Up to 2 years. |
| Objective response rate (ORR) assessed by investigators | Up to 2 years. |
| Adverse events (AEs) | Up to 2 years. |
| Duration of response (DoR) assessed by Independent Review Committee (IRC) | Up to 2 years. |
| Overall survival (OS) assessed by Independent Review Committee (IRC) | Up to 2 years. |
| Overall survival (OS) assessed by investigators | Up to 2 years. |
| Progression free survival (PFS) assessed by Independent Review Committee (IRC) | Up to 2 years. |
| Progression free survival (PFS) assessed by investigators | Up to 2 years. |
| Serious adverse events (SAEs) | Up to 2 years. |
Countries
China
Contacts
Primary ContactNa An
Outcome results
None listed