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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
93
a Selective PI3Kα Inhibitor
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.
Time frame: through study completion, an average of 1 year
PFS
PFS by BIRC using RECIST v1.1
Time frame: through study completion, an average of 1 year
OS
OS in each of the PIK3CA mutation status cohort
Time frame: through study completion, an average of 2 year
genetic and protein biomarker alterations
genetic and protein biomarker alterations that can impact PI3K signaling pathway
Time frame: through study completion, an average of 1 year
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Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, China
Chinese PLA General Hospital
Beijing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The Southwest Hospital of AMU
Chongqing, China
Sun Yat-sen University Cancer Center
Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangdong, China
The First Affiliated Hospital of Hainan Medical College
Haikou, China
The Third People's Hospital of Hainan Province
Hainan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
...and 26 more locations