Clinical Trials in Japan / 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 Japan tracker
Condition(s) studied
Ovarian CancerRecurrent Cancer
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
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)
- 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.
Trial sites (36)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Japan
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Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Active, not recruiting
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 Japan