A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma
NCT ID: NCT05043922
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
93 participants
INTERVENTIONAL
2021-10-11
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CYH33
40mg daily
CYH33
a Selective PI3Kα Inhibitor
Interventions
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CYH33
a Selective PI3Kα Inhibitor
Eligibility Criteria
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Inclusion Criteria
2. Provide informed consent voluntarily.
3. Patients must have histologically or cytologically confirmed recurrent or persistent ovarian, fallopian tube, or peritoneum clear cell carcinoma.
4. Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clear cell carcinoma, who have identified PIK3CA status.
5. Patients must have failed standard chemotherapy.
6. ECOG-PS ≤ 1.
7. Patient must have adequate organ and bone marrow function measured within 28 days of screening.
Exclusion Criteria
1. Patient has received any anticancer therapy
2. Patients who had prior treatment with any PI3K, mTOR or AKT inhibitor.
3. 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.
4. Any toxicities from prior treatment that have not recovered to baseline.
5. Patients who have been treated with any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug.
6. Patients who have symptomatic CNS metastasis.
7. 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.
8. 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.
9. History of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis.
10. Patients with clinically significant cardiovascular disease
18 Years
FEMALE
No
Sponsors
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Haihe Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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Other Identifiers
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CYH33-G201
Identifier Type: -
Identifier Source: org_study_id