A Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

NCT ID: NCT06840002

Last Updated: 2025-09-30

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-18

Study Completion Date

2026-07-31

Brief Summary

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The objective is to evaluate the tolerance, safety, pharmacokinetic characteristics and immunogenicity of SHR-A1811 combined with carboplatin and bevacizumab in the treatment of platinum sensitive recurrent epithelial ovarian cancer, and to determine the RP2D of the combination, and preliminarily to evaluate the effectiveness of SHR-A1811 combined regimen in the treatment of platinum sensitive recurrent epithelial ovarian cancer.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Group Type EXPERIMENTAL

SHR-A1811

Intervention Type DRUG

SHR-A1811.

Carboplatin

Intervention Type DRUG

Carboplatin.

Bevacizumab

Intervention Type DRUG

Bevacizumab.

Oxaliplatin for Injection

Intervention Type DRUG

Oxaliplatin for injection.

Paclitaxel injection

Intervention Type DRUG

Paclitaxel injection.

Doxorubicin hydrochloride liposome injection

Intervention Type DRUG

Doxorubicin hydrochloride liposome injetction.

Adebrelimab Injection

Intervention Type DRUG

Adebrelimab injection.

Interventions

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SHR-A1811

SHR-A1811.

Intervention Type DRUG

Carboplatin

Carboplatin.

Intervention Type DRUG

Bevacizumab

Bevacizumab.

Intervention Type DRUG

Oxaliplatin for Injection

Oxaliplatin for injection.

Intervention Type DRUG

Paclitaxel injection

Paclitaxel injection.

Intervention Type DRUG

Doxorubicin hydrochloride liposome injection

Doxorubicin hydrochloride liposome injetction.

Intervention Type DRUG

Adebrelimab Injection

Adebrelimab injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.
2. Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
3. At least one measurable lesion conforming to RECIST v1.1.
4. ECOG PS score: 0-1.
5. Expected survival ≥ 12 weeks.
6. Female subjects with fertility must agree to comply with the contraceptive requirements from signing the informed consent form to 7 months after the last administration of the trial drug.

Exclusion Criteria

1. With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
2. Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
3. Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
4. With hypertension and cannot be well controlled by antihypertensive drug treatment.
5. Accompanied by poorly controlled or serious cardiovascular diseases.
6. Subjects with serious infection within 1 month before the first medication.
7. Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
8. There are any other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, criminal detention, and other serious diseases (including mental illness) that need combined treatment.
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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Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuni Wang

Role: CONTACT

+86-0518-81220121

Facility Contacts

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Qinglei Gao

Role: primary

13871127473

Other Identifiers

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SHR-A1811-216-OC

Identifier Type: -

Identifier Source: org_study_id

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