A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian Cancer

Suzhou Suncadia Biopharmaceuticals Co., Ltd.520 enrolled

Overview

This is an open-label, randomized, controlled, two-part study to evaluate the safety and efficacy of SHR-A1921 with or without carboplatin verus investigator's choice of platinum-based doublet chemotherapy in subjects with recurrent epithelial ovarian cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

520

Conditions

Ovarian Cancer

Interventions

SHR-1921DRUG

SHR-1921

carboplatinDRUG

carboplatin AUC 4

carboplatinDRUG

carboplatin AUC 5

platinum-based doublet chemotherapy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Voluntary participation and written informed consent. 2. Be able to provide fresh or archived tumour tissue. 3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. 4. At least one measurable lesion according to RECIST v1.1. 5. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 6. With a life expectancy ≥ 12 weeks. 7. Adequate bone marrow reserve and organ function. Exclusion Criteria: 1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms. 2. Previous or co-existing malignancies. 3. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis; 4. Subjects with active hepatitis B or active hepatitis C; 5. Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment. 6. Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload. 7. Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.