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SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer | Clinical Trials | Clareo Health

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SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer

An Open-label, Randomized, Multicenter Phase III Clinical Trial of SHR - A1811 Versus Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer With HER2 Expression

NCT06990503•Tongji Hospital

View on ClinicalTrials.gov

Summary

This study is a randomized, open-label, active-controlled, multicenter phase III clinical trial. It is planned to enroll 300 subjects with platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with HER2 expression. The randomization will be stratified according to the following factors: 1) HER2 immunohistochemistry (IHC) expression status (HER2 IHC 1+ versus HER2 IHC 2+/3+); 2) whether the subject has previously received vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) inhibitors such as bevacizumab (yes versus no). Subjects will be randomly assigned in a 1:1 ratio to receive either the experimental treatment group (SHR - A1811) or the control treatment group (chemotherapy chosen by the investigator, namely liposomal doxorubicin, paclitaxel, topotecan, or gemcitabine).

Eligibility

Age

18 - 80 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. The patient voluntarily participates in this trial and signs the informed consent form.
•2. Female, aged 18 - 75 years old (including the boundary values, calculated from the date of signing the informed consent form).
•3. Pathologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer by tissue or cytology.
•4. Previously treated with a platinum - containing regimen and confirmed as platinum - resistant recurrence (platinum - resistant recurrence is defined as disease progression \[PD\] during platinum - containing therapy or within \<183 days after the last dose of platinum - containing drugs). If the patient has only received 1 line of platinum - containing treatment, at least 4 cycles of platinum - containing drugs must be received. The determination of platinum - resistant recurrence must have clear documented radiological progression. After platinum resistance, at most 1 line of systemic anti - tumor treatment has been received, and the patient is suitable for single - agent chemotherapy in the next line of treatment.
•5. Patients with known high expression of folate receptor α (FRα) must have received treatment with mirvetuximab soravtansine, unless the investigator judges that the patient is intolerant or unsuitable for mirvetuximab soravtansine treatment, or the treatment is not approved or unavailable locally, in which case they can be enrolled.
•6. Disease progression during or after the last - line treatment, or toxicity that is intolerable (with clear evidence).
•7. HER2 expression confirmed by the central laboratory: IHC 1+, 2+, or 3+; the patient needs to provide sufficient fresh or archived tumor tissue specimens for the sponsor - designated central laboratory to test the HER2 expression level (paraffin blocks, paraffin - embedded sections, or fresh tissue sections are all acceptable, and the scoring criteria for HER2 testing are determined by the central laboratory).
•8. At least one measurable lesion that meets the RECIST v1.1 criteria (according to the RECIST v1.1 requirements, the long diameter of the measurable lesion on spiral computed tomography \[CT\] scan is ≥10 mm or the short diameter of the enlarged lymph node is ≥15 mm); lesions that have been locally treated can be selected as target lesions if there is clear evidence that they have significantly progressed compared with the post - treatment state.
•9. ECOG PS score: 0 - 1 points.
•10. Expected survival time ≥12 weeks.
+25 more criteria

Exclusion Criteria

•1. Pathologically confirmed sarcoma histological subtypes, including hybrid tumors containing sarcomatous components.
•2. Subjects with untreated or active central nervous system (CNS) tumor metastases. Subjects with a history of leptomeningeal metastasis or current leptomeningeal metastasis. Subjects whose CNS tumor metastases have undergone adequate local treatment (surgery or radiotherapy), do not require hormone therapy, have neurologically returned to baseline (except for residual signs or symptoms related to CNS treatment), and have been stable for ≥4 weeks can be enrolled.
•3. Subjects who have previously received topoisomerase I inhibitors (including but not limited to irinotecan and topotecan), or ADC drugs containing topoisomerase I inhibitors, such as Enhertu (DS - 8201a), U3 - 1402, etc.
•4. Subjects who have received systemic anti - tumor treatment within 4 weeks before the start of the study treatment. If the previous anti - tumor treatment was small - molecule targeted therapy, the interval between the end of treatment and the first study treatment should be no less than 5 half - lives of the drug or 7 days.
•5. Subjects with symptomatic, poorly controlled, or moderate - to - severe pleural effusion, pericardial effusion, or ascites; subjects who have undergone effusion drainage (except diagnostic thoracentesis) can be enrolled if they have been stable for at least 2 weeks after drainage (local treatment within the serous cavity according to routine diagnosis and treatment is allowed before signing the informed consent form).
•6. Subjects who have completed palliative radiotherapy within 7 days before the first dose.
•7. Subjects with a history of other malignancies in the past or currently having other malignancies, except for cured basal cell carcinoma of the skin, cervical intraepithelial neoplasia, ductal carcinoma in situ of the breast, papillary thyroid carcinoma, and other malignancies that have been adequately treated and cured for ≥3 years before randomization with evidence proving no recurrence or metastasis.

Locations (1)

Tongji Hospital

Wuhan, Hubei, China

Key Dates

Start Date

June 1, 2025

Primary Completion Date

June 1, 2030

Completion Date

June 1, 2035

Last Updated

May 25, 2025

Enrollment

300

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

SHR-A1811

DRUG

Chemotherapy

DRUG

Contacts

Qinglei Gao

CONTACT

+86-27-83662681 qingleigao@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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SHR - A1811 Versus Chemotherapy for Platinum-resistant Recurrent Epithelial Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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