SHR-A1811 combination regimen for recurrent or metastatic cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label phase Ib/II trial that uses a dose-finding (phase Ib) then efficacy-expanding (phase II) design to study a combination regimen centered on SHR-A1811. The study will track tolerability, safety, pharmacokinetics, and immunogenicity while also looking for early signs of anti‑tumor activity. Investigational and approved agents in the regimen include SHR-A1811, adebelimab, bevacizumab, SHR-8068, and cisplatin, with dose escalation followed by expansion cohorts at selected doses. Eligible participants are adults with recurrent or metastatic cervical cancer who meet organ-function, survival expectancy, and contraceptive requirements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subjects must voluntarily join this study, sign the informed consent form, have good compliance and be able to cooperate with the follow-up.
2. Female, aged 18-75 years old.
3. Expected survival ≥ 12 weeks.
4. Normal function of vital organs.
5. 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.
6. 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.

Exclusion Criteria:

1. Previous or concomitant other malignancies.
2. Severe bone damage caused by bone metastasis from tumours.
3. Presence of active autoimmune disease or history of autoimmune disease with possible recurrence.
4. Those with active tuberculosis.
5. Concomitant poorly controlled or severe cardiovascular disease.
6. Occurrence of arteriovenous thrombotic events within 6 months prior to the first dose.
7. Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the first dose.
8. Subjects who have had a serious infection within 1 month before the first dose.
9. Subjects who have a history of immunodeficiency.
10. 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.

Where it's running

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Na An
• Email: na.an@hengrui.com
• Phone: +86-0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SHR-A1811 for HER2-positive recurrent or metastatic cervical cancer.

  This trial tests SHR-A1811 in people with HER2-expressing recurrent or metastatic cervical cancer whose disease did not respond to prior systemic therapy.

  Recruiting at 2 sites Phase 2 Jiangsu HengRui Medicine Co., Ltd. · Fuzhou, Fujian and 1 other locations · NCT07051486

• Using immune cells to treat recurrent or metastatic cervical cancer

  This study is testing if a new immune cell treatment can work better than a standard chemotherapy drug for people with recurrent or metastatic cervical cancer.

  Recruiting at 31 sites Phase 2 Grit Biotechnology · Beijing, Beijing Municipality and 37 other locations · NCT06241781

• Low-dose Pembrolizumab with Chemotherapy for Advanced Cervical Cancer

  This study is testing if a low dose of pembrolizumab combined with chemotherapy can help women with advanced cervical cancer who can't have curative treatments feel better.

  Recruiting Phase 2 Instituto Nacional de Cancer, Brazil · Rio de Janeiro, Rio de Janeiro · NCT06670911

• GLS-010 plus platinum chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer

  This phase 3 trial tests whether adding GLS-010 to standard platinum-based chemotherapy, with or without bevacizumab, can improve outcomes as first-line treatment for persistent, recurrent, or metastatic cervical cancer.

  Recruiting Phase 3 Guangzhou Gloria Biosciences Co., Ltd. · Shanghai, Shanghai Municipality · NCT05798819

• Reirradiation and Total Ablative Strategies for Recurrent Gynecologic Cancer (REGYNERA-tion) Registry

  This registry tests how reirradiation and total ablative strategies are used in real-world care for adults with recurrent gynecologic cancers and tracks outcomes to see what happens after these treatments.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość, Lublin Voivodeship · NCT07667192

• PD-1 versus PD-L1 immunotherapy combined with chemotherapy, with or without bevacizumab, for advanced cervical cancer.

  This trial tests whether giving PD-1 or PD-L1 immunotherapy alongside chemotherapy, with or without bevacizumab, helps adults with metastatic, persistent, or recurrent cervical cancer.

  Recruiting Phase 2/3 N.N. Alexandrov National Cancer Centre · Minsk, Lesnoy · NCT07472153

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.