SHR-A1811 combination regimen for 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

This trial tests a combination that includes the investigational agent SHR-A1811 with other cancer drugs to see if it helps people with recurrent or metastatic cervical cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06859775 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with recurrent or metastatic cervical cancer who have adequate organ function, an expected survival of at least 12 weeks, and who can follow contraception and study visit requirements are the intended candidates.

Not a fit: Patients with other active malignancies, uncontrolled cardiovascular disease, active autoimmune disease, active tuberculosis, severe bone damage from metastases, recent arteriovenous thrombotic events, or who cannot meet contraception requirements are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the combination could offer a new treatment option that prolongs disease control and improves symptoms for people with recurrent or metastatic cervical cancer.

How similar studies have performed: Other trials combining immune checkpoint agents with anti-angiogenic drugs and chemotherapy have shown activity in cervical cancer, so this approach builds on prior positive signals rather than being entirely untested.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Na An

Conditions Recurrent or Metastatic Cervical Cancer