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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043922
• Other study ID #: CYH33-G201
• Status: Recruiting
• Phase: Phase 2
• Start date: August 13, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Haihe Biopharma Co., Ltd.
• Contact: Xiaohua Wu, MD
• Phone: +86-21-6417-5590
• Email: wu.xh[@]fudan.eud.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Recurrence
• Recurrent Cancer

Intervention

Drug:
• CYH33
a Selective PI3Ka Inhibitor

Locations

Country	Name	City	State
China	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
Japan	National Cancer Center Hospital	Chuo Ku	Tokyo
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Shikoku Cancer Center	Matsuyama
Japan	Jikei University Hospital	Minato-Ku	Tokyo
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	Keio University Hospital	Shinjuku-Ku	Tokyo
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Haihe Biopharma Co., Ltd.

Countries where clinical trial is conducted

China,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability	type, incidence, duration, severity and seriousness of adverse events (AEs)	through study completion, an average of 1 year
Other	DLT (Dose Limiting Toxicity) in Japanese patients	Number and proportion of patients who experienced DLT during the first 28-day of treatment in Japanese patients in safety run-in study.	4 weeks
Other	Peak Plasma Concentration (Cmax)	Pharmacokinetics parameters	4weeks
Other	Area under the plasma concentration versus time curve (AUC)	Pharmacokinetics parameters	4weeks
Primary	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	PFS	PFS by BIRC using RECIST v1.1	through study completion, an average of 1 year
Secondary	OS	OS in each of the PIK3CA mutation status cohort	through study completion, an average of 2 year
Secondary	genetic and protein biomarker alterations	genetic and protein biomarker alterations that can impact PI3K signaling pathway	through study completion, an average of 1 year