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

Phase 2

Not yet recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: carboplatin; Drug: platinum-based doublet chemotherapy; Drug: SHR-1921

• Registration Number: NCT06211023
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18
• Study Start: 2024-02-15
• Primary Completion: 2026-06-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 520

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.

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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. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group 2: SHR-1921 + carboplatin dose level 1	carboplatin	-
Treatment group 4: platinum-based doublet chemotherapy	platinum-based doublet chemotherapy	-
Treatment group 1: SHR-1921	SHR-1921	-
Treatment group 3: SHR-1921 + carboplatin dose level 2	carboplatin	-

Primary Outcome Measures

Name	Time	Method
Objective Response Rate Assessed by Investigator According to RECIST v1.1	Screening up to study completion, an average of 1 year

Secondary Outcome Measures

Name	Time	Method
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