A Randomized, Open-Label, Controlled, Phase III Study of SHR-A1921 Versus Investigator's Choice of Chemotherapy in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Suzhou Suncadia Biopharmaceuticals Co., Ltd.2 sites in 1 country440 target enrollmentMay 10, 2024

ConditionsOvarian Cancer

InterventionsSHR-A1921 Doxorubicin Paclitaxel Topotecan

Overview

Phase: Phase 3
Intervention: SHR-A1921
Conditions: Ovarian Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 440
Locations: 2
Primary Endpoint: Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This study is a randomized, open-label, controlled, phase III study to evaluate the efficacy and safety of SHR-A1921 versus investigator's choice of chemotherapy in patients with platinum-resistant recurrent epithelial ovarian cancer.

Registry

clinicaltrials.gov

Start Date

May 10, 2024

End Date

December 31, 2026

Last Updated

last year

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.
•18 years and older, female.
•Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
•Patients must have platinum-resistant disease
•Be able to provide fresh or archived tumour tissue.
•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.
•Contraception is required during the trial.

Exclusion Criteria

•Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
•Previous or co-existing malignancies.
•Current or History of ILD.
•Clinical symptoms or diseases of the heart that are not well controlled.
•Arterial/venous thrombosis events occurred before the first dose.
•Grade ≥2 bleeding events of CTCAE occurred before the first dose.
•Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
•Patients with intestinal obstruction or parenteral nutrition before the first dose.
•Serious infection before the first dose.
•Active hepatitis B or active hepatitis C.

Arms & Interventions

Treatment group 1: SHR-A1921

Intervention: SHR-A1921

Treatment group 2: Investigator's choice of chemotherapy

Intervention: Doxorubicin

Treatment group 2: Investigator's choice of chemotherapy

Intervention: Paclitaxel

Treatment group 2: Investigator's choice of chemotherapy

Intervention: Topotecan

Outcomes

Primary Outcomes

Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1

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

Secondary Outcomes

CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria(Screening up to study completion, an average of 1 year)
Adverse Events(Screening up to study completion, an average of 1 year)
Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
Duration of Response (DoR), assessed by site investigator as per RECIST 1.1(Screening up to study completion, an average of 1 year)
Overall Survival (OS)(Screening up to study completion, an average of 1 year)
Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria(Screening up to study completion, an average of 1 year)