SHR-A1921 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer

Phase 3

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: SHR-A1921; Drug: Doxorubicin; Drug: Paclitaxel; Drug: Topotecan

• Registration Number: NCT06394492
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-04-27
• Study First Posted: 2024-05-01
• Study Start: 2024-05-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Primary Completion: 2026-05-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 440

Inclusion Criteria

1. Voluntary participation and written informed consent.
2. 18 years and older, female.
3. Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
4. Patients must have platinum-resistant disease
5. Be able to provide fresh or archived tumour tissue.
6. At least one measurable lesion according to RECIST v1.1.
7. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
8. With a life expectancy ≥ 12 weeks.
9. Adequate bone marrow reserve and organ function.
10. Contraception is required during the trial.

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Exclusion Criteria

1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
2. Previous or co-existing malignancies.
3. Current or History of ILD.
4. Clinical symptoms or diseases of the heart that are not well controlled.
5. Arterial/venous thrombosis events occurred before the first dose.
6. Grade ≥2 bleeding events of CTCAE occurred before the first dose.
7. Gastrointestinal perforation or fistula, urethral fistula, abdominal abscess occurred before the first dose.
8. Patients with intestinal obstruction or parenteral nutrition before the first dose.
9. Serious infection before the first dose.
10. Active hepatitis B or active hepatitis C.
11. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
12. Treated with TOP1 inhibitors or ADCs with TOP1 inhibitors as payload.
13. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
14. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921.
15. Other inappropriate situation considered by the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 1: SHR-A1921	SHR-A1921	-
Treatment group 2: Investigator's choice of chemotherapy	Doxorubicin	-
Treatment group 2: Investigator's choice of chemotherapy	Topotecan	-
Treatment group 2: Investigator's choice of chemotherapy	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) assessed by Blinded Independ Review Committee (BIRC) as per RECIST 1.1	Screening up to study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
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
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
Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1	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

Trial Locations

Locations (2)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China