A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma
- Registration Number
- NCT05043922
- Lead Sponsor
- Haihe Biopharma Co., Ltd.
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 86
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CYH33 CYH33 40mg daily
- Primary Outcome Measures
Name Time Method Tumor ORR in patients with PIK3CA hotspot mutations. through study completion, an average of 1 year Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations.
- Secondary Outcome Measures
Name Time Method OS through study completion, an average of 2 year OS in each of the PIK3CA mutation status cohort
genetic and protein biomarker alterations through study completion, an average of 1 year genetic and protein biomarker alterations that can impact PI3K signaling pathway
PFS through study completion, an average of 1 year PFS by BIRC using RECIST v1.1
Trial Locations
- Locations (36)
National Cancer Center Hospital
🇯🇵Chuo Ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
Harbin Medical University Cancer Hospital
🇨🇳Harbin, China
The Southwest Hospital of AMU
🇨🇳Chongqing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangdong, China
The First Affiliated Hospital of Hainan Medical College
🇨🇳Haikou, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Hubei Cancer Hospital
🇨🇳Hubei, China
The People's Hospital Of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
🇨🇳Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangdong, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Shanghai First Maternity and Infant Hospital
🇨🇳Shanghai, China
West China Second University Hospital, Sichuan University
🇨🇳Sichuan, China
Sir Run Run Shaw Hospital， School of Medicine, Zhejiang University
🇨🇳Zhejiang, China
Niigata University Medical & Dental Hospital
🇯🇵Niigata, Japan
The Third People's Hospital of Hainan Province
🇨🇳Hainan, China
Hunan Cancer Hospital
🇨🇳Hunan, China
Qingdao Central Hospital
🇨🇳Qingdao, China
Obstetrics & Gynecology Hospital of Fudan University
🇨🇳Shanghai, China
Xiaohua wu
🇨🇳Shanghai, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, China
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Osaka University Hospital
🇯🇵Suita, Osaka, Japan
Shikoku Cancer Center
🇯🇵Matsuyama, Japan
Jikei University Hospital
🇯🇵Minato-Ku, Tokyo, Japan
Nagoya University Hospital
🇯🇵Nagoya, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Tohoku University Hospital
🇯🇵Sendai, Japan
Jiangsu Province Hospital
🇨🇳Nanjing, China