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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Ovarian Cancer

Treatments: Drug: carboplatin; Drug: SHR-1921; Drug: platinum-based doublet chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT06211023

SHR-A1921-301

Details and patient eligibility

About

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.

Enrollment: 520 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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520 participants in 4 patient groups

Treatment group 1: SHR-1921

Experimental group

Treatment:

Drug: SHR-1921

Treatment group 2: SHR-1921 + carboplatin dose level 1

Experimental group

Treatment:

Drug: carboplatin

Drug: carboplatin

Treatment group 3: SHR-1921 + carboplatin dose level 2

Experimental group

Treatment:

Drug: carboplatin

Drug: carboplatin

Treatment group 4: platinum-based doublet chemotherapy

Other group

Treatment:

Drug: platinum-based doublet chemotherapy