Status:
NOT_YET_RECRUITING
A Study of SHR-A1921 With or Without Carboplatin in Subjects With Ovarian Cancer
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
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 chemoth...
Eligibility Criteria
Inclusion
- Voluntary participation and written informed consent.
- Be able to provide fresh or archived tumour tissue.
- Pathologically diagnosed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
- At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- With a life expectancy ≥ 12 weeks.
- Adequate bone marrow reserve and organ function.
Exclusion
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- Previous or co-existing malignancies.
- Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
- Subjects with active hepatitis B or active hepatitis C;
- Subjects who have received systemic anti-tumor treatments 4 weeks prior to the initiation of the study treatment.
- Subjects who have been treated with TOP1 inhibitors, TROP-2 ADC or ADCs with TOP1 inhibitors as payload.
- Has unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2026
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT06211023
Start Date
February 15 2024
End Date
June 15 2026
Last Update
January 18 2024
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