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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent or Metastatic Cervical Cancer
• Intervention / Treatment: Drug: SHR-A1811; Drug: Adebelimab injection; Drug: Bevacizumab injection; Drug: SHR-8068; Drug: Cisplatin injection; Drug: Carboplatin injection

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Na An; Phone Number: +86-0518-82342973; Email: na.an@hengrui.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Contact: Yang Xiang; Phone Number: +86-010-69156086; Email: XiangY@pumch.cn
      • Principal Investigator: Yang Xiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment cohort 1	Drug: SHR-A1811; SHR-A1811 injection.; Drug: Adebelimab injection; Adebelimab injection.; Drug: Bevacizumab injection; Bevacizumab injection.
Experimental: Treatment cohort 2	Drug: SHR-A1811; SHR-A1811 injection.; Drug: Adebelimab injection; Adebelimab injection.; Drug: Bevacizumab injection; Bevacizumab injection.; Drug: SHR-8068; SHR-8068 injection.
Experimental: Treatment cohort 3	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Recurrence; Uterine Cervical Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Carboplatin
• Other Study ID Numbers: SHR-A1811-216-CC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No