A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma
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
1 other identifier
interventional
93
2 countries
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 ovarian-cancer
Started Oct 2021
Typical duration for phase_2 ovarian-cancer
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2021
CompletedFirst Posted
Study publicly available on registry
September 14, 2021
CompletedStudy Start
First participant enrolled
October 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedJanuary 30, 2026
January 1, 2026
2.8 years
August 30, 2021
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
PFS
through study completion, an average of 1 year
OS
through study completion, an average of 2 year
genetic and protein biomarker alterations
through study completion, an average of 1 year
Other Outcomes (4)
Safety and tolerability
through study completion, an average of 1 year
DLT (Dose Limiting Toxicity) in Japanese patients
4 weeks
Peak Plasma Concentration (Cmax)
4weeks
- +1 more other outcomes
Study Arms (1)
CYH33
EXPERIMENTAL40mg daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
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
Harbin Medical University Cancer Hospital
Harbin, China
Hubei Cancer Hospital
Hubei, China
Hunan Cancer Hospital
Hunan, China
Qilu Hospital of Shandong University
Jinan, China
Jiangsu Province Hospital
Nanjing, China
The People's Hospital Of Guangxi Zhuang Autonomous Region
Nanning, China
Qingdao Central Hospital
Qingdao, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China
Shanghai First Maternity and Infant Hospital
Shanghai, China
Xiaohua wu
Shanghai, China
West China Second University Hospital, Sichuan University
Sichuan, China
Tianjin Medical University General Hospital
Tianjin, China
Zhongnan Hospital of Wuhan University
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Sir Run Run Shaw Hospital， School of Medicine, Zhejiang University
Zhejiang, China
Kurume University Hospital
Kurume, Fukuoka, Japan
Osaka University Hospital
Suita, Osaka, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
Jikei University Hospital
Minato-Ku, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Shikoku Cancer Center
Matsuyama, Japan
Nagoya University Hospital
Nagoya, Japan
Niigata University Medical & Dental Hospital
Niigata, Japan
Okayama University Hospital
Okayama, Japan
Hokkaido University Hospital
Sapporo, Japan
Tohoku University Hospital
Sendai, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2021
First Posted
September 14, 2021
Study Start
October 11, 2021
Primary Completion
July 31, 2024
Study Completion
February 28, 2026
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share