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New treatment option for Recurrent or Metastatic Cervical Cancer
Official title A Phase II Trial of SHR-A1811 in HER2-Expressing Recurrent/Metastatic Cervical Cancer
ClinicalTrials.gov ID: NCT07051486
What this study is testing
What is SHR-A1811 Injection?
SHR-A1811 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for recurrent or metastatic cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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.
You likely can't join if
- people with known untreated or active central nervous system (CNS) tumor metastases.
- people with other malignant tumors in the past or at the same time.
- people with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.
- people with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
- people with autoimmune, connective tissue or inflammatory diseases involving the lungs.
- people with known lung damage caused by concurrent lung diseases.
See the full eligibility 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 people 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...
- people with known untreated or active central nervous system (CNS) tumor metastases.
- people with other malignant tumors in the past or at the same time.
- people with clinically symptomatic, poorly controlled, or moderate or greater pleural effusion, pericardial effusion or peritoneal effusion.
- people with a history of interstitial pneumonia/interstitial lung disease or non-infectious pneumonia requiring steroid treatment.
- people with autoimmune, connective tissue or inflammatory diseases involving the lungs.
- people with known lung damage caused by concurrent lung diseases.
- people with active pulmonary tuberculosis.
- people with poorly controlled or severe cardiovascular diseases.
- people with arterial/venous thrombotic events within 1 month before enrollment.
- people who had a serious infection within 1 month before enrollment.
- History of immunodeficiency, including positive HIV test.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.