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

NCT ID: NCT06859775

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-25

Study Completion Date

2027-01-31

Brief Summary

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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

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Conditions

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Recurrent or Metastatic Cervical Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment cohort 1

Group Type EXPERIMENTAL

SHR-A1811

Intervention Type DRUG

SHR-A1811 injection.

Adebelimab injection

Intervention Type DRUG

Adebelimab injection.

Bevacizumab injection

Intervention Type DRUG

Bevacizumab injection.

Treatment cohort 2

Group Type EXPERIMENTAL

SHR-A1811

Intervention Type DRUG

SHR-A1811 injection.

Adebelimab injection

Intervention Type DRUG

Adebelimab injection.

Bevacizumab injection

Intervention Type DRUG

Bevacizumab injection.

SHR-8068

Intervention Type DRUG

SHR-8068 injection.

Treatment cohort 3

Group Type EXPERIMENTAL

SHR-A1811

Intervention Type DRUG

SHR-A1811 injection.

Adebelimab injection

Intervention Type DRUG

Adebelimab injection.

Bevacizumab injection

Intervention Type DRUG

Bevacizumab injection.

SHR-8068

Intervention Type DRUG

SHR-8068 injection.

Cisplatin injection

Intervention Type DRUG

Cisplatin injection.

Carboplatin injection

Intervention Type DRUG

Carboplatin injection.

Interventions

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SHR-A1811

SHR-A1811 injection.

Intervention Type DRUG

Adebelimab injection

Adebelimab injection.

Intervention Type DRUG

Bevacizumab injection

Bevacizumab injection.

Intervention Type DRUG

SHR-8068

SHR-8068 injection.

Intervention Type DRUG

Cisplatin injection

Cisplatin injection.

Intervention Type DRUG

Carboplatin injection

Carboplatin injection.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Na An

Role: CONTACT

+86-0518-82342973

Facility Contacts

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Yang Xiang

Role: primary

+86-010-69156086

Other Identifiers

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SHR-A1811-216-CC

Identifier Type: -

Identifier Source: org_study_id

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