SHR-A1811 Combination Regimen for the Treatment of Recurrent or Metastatic Cervical Cancer

Phase 1

Not yet recruiting

• Conditions: Recurrent or Metastatic Cervical Cancer
• Interventions: Drug: SHR-A1811; Drug: Adebelimab injection; Drug: Bevacizumab injection; Drug: SHR-8068; Drug: Cisplatin injection; Drug: Carboplatin injection

• Registration Number: NCT06859775
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-27
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study Start: 2025-03
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-10
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment cohort 1	SHR-A1811	-
Treatment cohort 1	Adebelimab injection	-
Treatment cohort 1	Bevacizumab injection	-
Treatment cohort 2	SHR-A1811	-
Treatment cohort 2	Adebelimab injection	-
Treatment cohort 2	Bevacizumab injection	-
Treatment cohort 2	SHR-8068	-
Treatment cohort 3	SHR-A1811	-
Treatment cohort 3	Adebelimab injection	-
Treatment cohort 3	Bevacizumab injection	-
Treatment cohort 3	SHR-8068	-
Treatment cohort 3	Cisplatin injection	-
Treatment cohort 3	Carboplatin injection	-

Primary Outcome Measures

Name	Time	Method
Grade≥3 drug-related adverse events (TRAEs).	Up to 3 years.
Grade≥3 drug-related serious adverse events (TRAEs).	Up to 3 years.
Objective response rate (ORR).	Up to 3 years.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR).	Up to 3 years.
Disease control rate (DCR).	Up to 3 years.
Progression-free survival (PFS).	Up to 3 years.
Overall survival (OS).	Up to 3 years.

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China