A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to determine the treatment efficacy of CYH33 monotherapy in patients with recurrent or persistent ovarian, fallopian tube or primary peritoneal clear cell carcinoma harboring PIK3CA hotspot mutation, who received prior systemic anti-tumor treatment.

Detailed Description
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The purpose of this study is to determine whether treatment with single agent CYH33 significantly improves ORR compared to historical efficacy data in patients with recurrent/persistent ovarian clear cell carcinoma (OCCC) harboring PIK3CA hotspot mutations who received prior systemic anti-tumor treatment.

Official Title
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A Phase II, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of CYH33, a Selective PI3Kα Inhibitor in Patients With Recurrent/Persistent Ovary, Fallopian Tube or Primary Peritoneal Clear Cell Carcinoma

Conditions
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Ovarian Cancer, Recurrent Cancer

Intervention / Treatment
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* Drug: CYH33


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Female patients ≥ 18 years of age Provide informed consent voluntarily. Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma. Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status. Patients must have failed standard chemotherapy. ECOG-PS ≤ 1. Patient must have adequate organ and bone marrow function measured within 28 days of screening. Main Exclusion Criteria: Patients are ineligible for this study if they meet any of the following criteria: Patient has received any anticancer therapy Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor. Radical radiation therapy within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks. Any toxicities from prior treatment that have not recovered to baseline. Patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug. Patients who have symptomatic CNS metastasis. Major surgery or had significant traumatic injury within 28 days prior to the first dose of the investigational product or has not recovered from major side effects. Known HIV infection with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunity infection within the past 12 months; active hepatitis B and hepatitis C. History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis. Patients with clinically significant cardiovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CYH33<br>40mg daily | Drug: CYH33<br>* a Selective PI3Kα Inhibitor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor ORR in patients with PIK3CA hotspot mutations. | Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | PFS by BIRC using RECIST v1.1 | through study completion, an average of 1 year | 
| OS | OS in each of the PIK3CA mutation status cohort | through study completion, an average of 2 year | 
| genetic and protein biomarker alterations | genetic and protein biomarker alterations that can impact PI3K signaling pathway | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 2 study, Pharmacokinetics