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

NCT06840002 | Recruiting Phase 1

• 1 other identifier: SHR-A1811-216-OC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• Dose limited toxicity (DLT)

  Up to 21 days.

• Recommended phase II dose (RP2D)

  Up to 21 days.

• Objective response rate (ORR)

  Every 9 weeks lasting about one year.

Secondary Outcomes (7)

• Duration of response (DoR)

  Every 9 weeks lasting about one year.

• Disease control rate (DCR)

  Every 9 weeks lasting about one year.

• Progression free survival (PFS)

  Every 9 weeks lasting about one year.

• Standard response rate (RR)

  Every 9 weeks lasting about one year.

• Overall survival (OS)

  Approximately 3 years after the last subject enrolled.

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: SHR-A1811; Drug: Carboplatin; Drug: Bevacizumab; Drug: Oxaliplatin for Injection; Drug: Paclitaxel injection; Drug: Doxorubicin hydrochloride liposome injection; Drug: Adebrelimab Injection

Interventions

SHR-A1811 DRUG

SHR-A1811.

Treatment group

Carboplatin DRUG

Carboplatin.

Treatment group

Bevacizumab DRUG

Bevacizumab.

Treatment group

Oxaliplatin for Injection DRUG

Oxaliplatin for injection.

Treatment group

Paclitaxel injection DRUG

Paclitaxel injection.

Treatment group

Doxorubicin hydrochloride liposome injection DRUG

Doxorubicin hydrochloride liposome injetction.

Treatment group

Adebrelimab Injection DRUG

Adebrelimab injection.

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily join this study, sign the informed consent form, have good compliance, and can cooperate with the follow-up.
• Sufficient fresh or archived tumor tissue specimens can be provided for testing by the third-party central laboratory designated by the sponsor.
• At least one measurable lesion conforming to RECIST v1.1.
• ECOG PS score: 0-1.
• Expected survival ≥ 12 weeks.
• 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.

You may not qualify if:

• With untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis.
• Pleural effusion, pericardial effusion or peritoneal effusion with clinical symptoms, which cannot be well controlled.
• Previous interstitial pneumonia or interstitial lung disease, non infectious pneumonia requiring steroid treatment.
• With hypertension and cannot be well controlled by antihypertensive drug treatment.
• Accompanied by poorly controlled or serious cardiovascular diseases.
• Subjects with serious infection within 1 month before the first medication.
• Have a history of immune deficiency, including HIV test positive, other acquired or congenital immune deficiency diseases, or a history of organ transplantation.
• 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.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin; Bevacizumab; Oxaliplatin; Injections; Paclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Central Study Contacts

Shuni Wang

CONTACT

+86-0518-81220121; shuni.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: March 18, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-04

Locations

CN (1)