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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06394492
• Other study ID #: SHR-A1921-303
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 31, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Shuni Wang
• Phone: +86 021-61053363
• Email: shuni.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 440
• Est. completion date: December 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• SHR-A1921
SHR-A1921 dose 1
• Doxorubicin
Doxorubicin dose 2
• Paclitaxel
Paclitaxel dose 3
• Topotecan
Topotecan dose 4

Locations

Country	Name	City	State
China	National Cancer Center/Tumor Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) assessed by site investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Overall Survival (OS)		Screening up to study completion, an average of 1 year
Secondary	Objective Response Rate (ORR), assessed by site investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Duration of Response (DoR), assessed by site investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Disease Control Rate (DCR), assessed by site investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Response Rate (RR) assessed by RECIST 1.1 and Gynaecologic Cancer Intergroup (GCIG) criteria		Screening up to study completion, an average of 1 year
Secondary	CA-125 Response Rate assessed by the Gynaecologic Cancer Intergroup (GCIG) criteria		Screening up to study completion, an average of 1 year
Secondary	Adverse Events		Screening up to study completion, an average of 1 year