Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer (NCT06859775) is a Phase 1 / Phase 2 interventional studying Recurrent or Metastatic Cervical Cancer, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Recurrent or Metastatic Cervical Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Recurrent or Metastatic Cervical Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects must voluntarily join this study, sign the willing to sign a consent form 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 willing to sign a consent form form to 7 months after the last dose of the investigational drug. Who Should NOT Join This Trial: 1. Previous or concomitant other malignancies. 2. Severe bone damage caused by bone metastasis from tumours. 3. Presence of active autoimmune conditions (where your immune system attacks your own body) or history of autoimmune conditions (where your immune system attacks your own body) 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 weakened immune system. 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

SHR-A1811

SHR-A1811 injection.

DRUG

Adebelimab injection

Adebelimab injection.

DRUG

Bevacizumab injection

Bevacizumab injection.

DRUG

SHR-8068

SHR-8068 injection.

DRUG

Cisplatin injection

Cisplatin injection.

DRUG

Carboplatin injection

Carboplatin injection.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06859775), the sponsor (Suzhou Suncadia Biopharmaceuticals Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06859775 clinical trial studying?

Who can participate in NCT06859775?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06859775?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06859775. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06859775. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.