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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06211023
• Other study ID #: SHR-A1921-301
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: February 15, 2024
• Est. completion date: June 15, 2026

Study information

• Verified date: January 2024
• Source: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• Contact: Yuanchao Wang
• Phone: 0518-81220278
• Email: yuanchao.wang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 520
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• SHR-1921
SHR-1921
• carboplatin
carboplatin AUC 4
• carboplatin
carboplatin AUC 5
• platinum-based doublet chemotherapy
platinum-based doublet chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate Assessed by Investigator According to RECIST v1.1		Screening up to study completion, an average of 1 year
Secondary	Duration of Response (DoR) Assessed by Investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Disease Control Rate (DCR) Assessed by Investigator as per RECIST 1.1		Screening up to study completion, an average of 1 year
Secondary	Progression-Free Survival (PFS) Assessed by 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	CA-125 Response assessed by the Gynecologic Cancer Intergroup (GCIG) criteria		Screening up to study completion, an average of 1 year