Recruiting NCT07051486
A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1811 Injection.
- Who it may be relevant to
- Registry conditions: Recurrent or Metastatic Cervical Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm, Multicenter Phase II Clinical Trial of SHR-A1811 for Injection in Patients With HER2-Expressing Recurrent or Metastatic Cervical Cancer Progressing After Standard Treatment
Overview
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
- Drug SHR-A1811 Injection
SHR-A1811 for injection.
Primary outcome measures
- Objective response rate (ORR) assessed by Independent Review Committee (IRC) [Time frame: Up to 2 years.]
Secondary outcome measures (11)
- Overall survival (OS) assessed by Independent Review Committee (IRC) [Time frame: Up to 2 years.]
- Overall survival (OS) assessed by investigators [Time frame: Up to 2 years.]
- Progression free survival (PFS) assessed by Independent Review Committee (IRC) [Time frame: Up to 2 years.]
- Progression free survival (PFS) assessed by investigators [Time frame: Up to 2 years.]
- Duration of response (DoR) assessed by Independent Review Committee (IRC) [Time frame: Up to 2 years.]
- Duration of response (DoR) assessed by investigators [Time frame: Up to 2 years.]
- Disease control rate (DCR) assessed by Independent Review Committee (IRC) [Time frame: Up to 2 years.]
- Disease control rate (DCR) assessed by investigators [Time frame: Up to 2 years.]
- Objective response rate (ORR) assessed by investigators [Time frame: Up to 2 years.]
- Adverse events (AEs) [Time frame: Up to 2 years.]
- Serious adverse events (SAEs) [Time frame: Up to 2 years.]
Eligibility criteria
Inclusion criteria
- Voluntarily join this study, sign the informed consent, have good compliance, and can cooperate with follow-up.
- Female, aged 18-75 years old (including 18 and 75 years old, calculated on the day of signing the informed consent).
- Cervical cancer confirmed by tissue or cytological pathology.
- Expected survival ≥ 12 weeks.
- Normal function of important organs.
- 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
- Subjects with known untreated or active central nervous system (CNS) tumor metastases.
- Subjects with other malignant tumors in the past or at the same time.
- Subjects with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.
- Subjects with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
- Subjects with autoimmune, connective tissue or inflammatory diseases involving the lungs.
- Subjects with known lung damage caused by concurrent lung diseases.
- Subjects with active pulmonary tuberculosis.
- Subjects with poorly controlled or severe cardiovascular diseases.
- Subjects with arterial/venous thrombotic events within 1 month before enrollment.
- Subjects who had a serious infection within 1 month before enrollment.
- History of immunodeficiency, including positive HIV test.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Fujian Cancer Hospital — Fuzhou
- Shandong University Qilu Hospital — Jinan
Identifiers
NCT: NCT07051486 · SHR-A1811-218