An Open-label, Randomized, Controlled, Phase II/III Study of SHR-A1921 With or Without Carboplatin Verus Investigator's Choice of Platinum-based Doublet Chemotherapy in Patients With Recurrent Epithelial Ovarian Cancer

Suzhou Suncadia Biopharmaceuticals Co., Ltd.0 sites520 target enrollmentFebruary 15, 2024

ConditionsOvarian Cancer

InterventionsSHR-1921 carboplatin platinum-based doublet chemotherapy

DrugsSHR-1921 carboplatin platinum-based doublet chemotherapy

Overview

Phase: Phase 2
Intervention: SHR-1921
Conditions: Ovarian Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 520
Primary Endpoint: Objective Response Rate Assessed by Investigator According to RECIST v1.1
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 15, 2024

End Date

June 15, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntary participation and written informed consent.
•Be able to provide fresh or archived tumour tissue.
•Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
•At least one measurable lesion according to RECIST v1.
•Eastern Cooperative Oncology Group (ECOG) score: 0-
•With a life expectancy ≥ 12 weeks.
•Adequate bone marrow reserve and organ function.

Exclusion Criteria

•Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
•Previous or co-existing malignancies.
•Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
•Subjects with active hepatitis B or active hepatitis C;
•Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
•Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload.
•Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.

Arms & Interventions

Treatment group 1: SHR-1921

Intervention: SHR-1921

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

Intervention: carboplatin

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

Intervention: carboplatin

Treatment group 4: platinum-based doublet chemotherapy

Intervention: platinum-based doublet chemotherapy

Outcomes

Primary Outcomes

Objective Response Rate Assessed by Investigator According to RECIST v1.1

Time Frame: Screening up to study completion, an average of 1 year

Secondary Outcomes

Overall Survival (OS)(Screening up to study completion, an average of 1 year)
CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria(Screening up to study completion, an average of 1 year)
Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
Progression-Free Survival (PFS) Assessed by Investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)