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NCT Number: NCT06840002

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Wuhan, Hubei, 430000, China

Location status: Recruiting

Location contact

Qinglei Gao

CONTACT

[email protected]

13871127473

Qinglei Gao

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR-A1811

Drug

SHR-A1811.

carboplatin

Drug

Carboplatin.

Bevacizumab

Drug

Bevacizumab.

Oxaliplatin for injection

Drug

Oxaliplatin for injection.

Paclitaxel Injection

Drug

Paclitaxel injection.

Doxorubicin hydrochloride liposome injection

Drug

Doxorubicin hydrochloride liposome injetction.

Adebrelimab Injection

Drug

Adebrelimab injection.

Primary outcomes

  1. Dose limited toxicity (DLT)

    Time frame: Up to 21 days.

  2. Recommended phase II dose (RP2D)

    Time frame: Up to 21 days.

  3. Objective response rate (ORR)

    Time frame: Every 9 weeks lasting about one year.

Secondary outcomes

  1. Duration of response (DoR)

    Time frame: Every 9 weeks lasting about one year.

  2. Disease control rate (DCR)

    Time frame: Every 9 weeks lasting about one year.

  3. Progression free survival (PFS)

    Time frame: Every 9 weeks lasting about one year.

  4. Standard response rate (RR)

    Time frame: Every 9 weeks lasting about one year.

  5. Overall survival (OS)

    Time frame: Approximately 3 years after the last subject enrolled.

  6. Adverse events (AEs)

    Time frame: From the first drug administration to within 90 days after the last dose.

  7. Serious adverse events (SAEs)

    Time frame: From the first drug administration to within 90 days after the last dose.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

An Open, Multicenter Phase Ib / II Clinical Study of SHR-A1811 Combined With Chemotherapy for Platinum Sensitive Recurrent Ovarian Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2025
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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