A Study of SHR-A1811 in Subjects With Ovarian Cancer

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: Ovarian Cancer

Treatments: Drug: Topotecan Hydrochloride for Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: SHR-A1811; Drug: Paclitaxel Injection; Drug: Doxorubicin Hydrochloride Liposome Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06828354

SHR-A1811-315

Details and patient eligibility

About

This is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subjects voluntarily joined the study and signed the Informed consent forms (ICF).
2. Measurable disease, as defined by RECIST v1.1.
3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1.
4. Life expectancy ≥ 12 weeks.

Exclusion criteria

1. Symptomatic, untreated or active central nervous system metastases.
2. Have uncontrolled or severe cardiovascular disease.
3. With any active autoimmune disease or history of autoimmune disease.
4. Patients with active hepatitis B or hepatitis C.
5. Severe infections prior to initiation of study treatment.
6. Patients with active tuberculosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

SHR-A1811 group

Experimental group

Treatment:

Drug: SHR-A1811

Chemotherapy group

Active Comparator group

Treatment:

Drug: Doxorubicin Hydrochloride Liposome Injection

Drug: Paclitaxel Injection

Drug: Gemcitabine Hydrochloride for Injection

Drug: Topotecan Hydrochloride for Injection