NCT06859775RecruitingPhase 1/2
SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer
Open-label, Multicenter Phase Ib/II Clinical Study of Injectable SHR-A1811 in Combination Regimens for the Treatment of Recurrent or Metastatic Cervical Cancer
Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is a multicentre, open-label, dose-finding/efficacy-expanding phase Ib/II clinical trial to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of SHR-A1811 combination regimen in the treatment of recurrent or metastatic cervical cancer and to preliminarily evaluate the efficacy of SHR-A1811 combination regimen for recurrent or metastatic cervical cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 27 Feb 2025
- Start date
- 25 Apr 2025
- Primary completion date
- Oct 2026
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Cervical cancer
- NCT number
- NCT06859775
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 100
- From 25 Apr 2025 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or concomitant other malignancies.
- Concomitant poorly controlled or severe cardiovascular disease.
- Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
- Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
- Subjects who have had a serious infection within 1 month before the first dose.
Other illness
- Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
- Those with active tuberculosis.
- Subjects who have a history of immunodeficiency.
Other
- Severe bone damage caused by bone metastasis from tumours.
- As judged by the investigator, there are other factors that may affect the results of the study or cause the study to be forced to terminate halfway.
Who the study is looking for
- Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
- Female, aged 18-75 years old.
- Expected survival ≥ 12 weeks.
- Normal function of vital organs.
- Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to the first dose and must be non-lactating.
- Female subjects must agree to comply with contraceptive requirements from signing the informed consent form to 7 months after the last dose of the investigational drug.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.