NCT06859775 SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer
| NCT ID | NCT06859775 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | Recurrent or Metastatic Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-25 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-04-25 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06859775 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Recurrent or Metastatic Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06859775 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06859775 currently recruiting?
Yes, NCT06859775 is actively recruiting participants. Contact the research team at na.an@hengrui.com for enrollment information.
Where is the NCT06859775 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06859775 clinical trial?
NCT06859775 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 100 participants.
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