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Recruiting Phase 2 NCT06560112

NCT06560112 An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer

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Clinical Trial Summary
NCT ID NCT06560112
Status Recruiting
Phase Phase 2
Sponsor Akeso
Condition Recurrent Ovarian Cancer
Study Type INTERVENTIONAL
Enrollment 172 participants
Start Date 2024-11-12
Primary Completion 2026-05-01

Trial Parameters

Condition Recurrent Ovarian Cancer
Sponsor Akeso
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 172
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-11-12
Completion 2026-05-01
Interventions
AK104AK112Chemotherapy

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Brief Summary

An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer

Eligibility Criteria

Inclusion Criteria: 1. Signs the written informed consent form. 2. Female participants who are at least 18 years of age on the day of signing informed consent with. 3. ECOG of 0 or 1. 4. Life expectancy ≥ 3 months. 5. Histologically diagnosed high-grade epithelial ovarian cancer (including high-grade serous, clear cell, G3 endometrioid) that has relapsed after platinum-containing standard chemotherapy. 1. Recurrence of Platinum-sensitive (relapse ≥6 months after the end of platinum-containing therapy) who is not suitable for platinum-containing therapy after ≥ 3 lines of therapy; 2. Recurrence of platinum resistance , ≤3 previous lines of therapy. Note: Ovarian cancer includes ovarian cancer, fallopian tube cancer and primary peritoneal cancer in this study, unless otherwise specified. 6. Has measurable disease based on RECIST v1.1 as determined by the site study team. 7. Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue. 8. Has adequate organ function. 9. All su

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