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Clinical Trials in China / NCT05043922
Active, not recruiting Phase 2

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

NCT05043922 · tracked via the Priya Life Science China tracker
Sponsor
Haihe Biopharma Co., Ltd.
Phase
Phase 2
Started
2021-10-11
Last updated
2026-01-30

Condition(s) studied

Ovarian CancerRecurrent Cancer

Investigational drug(s) / intervention(s)

CYH33

CYH33: a Selective PI3Kα Inhibitor

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
Main Inclusion Criteria: 1. Female patients ≥ 18 years of age 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. Main Exclusion Criteria: Patients are ineligible for this study if they meet any of the following 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

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
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
Osaka University Hospital Suita Osaka
National Cancer Center Hospital Chuo Ku Tokyo
Jikei University Hospital Minato-Ku Tokyo
Keio University Hospital Shinjuku-Ku Tokyo
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

More Haihe Biopharma Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05043922 on ClinicalTrials.gov ↗ ← All trials in China