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

Primary Purpose

Ovarian Cancer, Recurrent Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CYH33
Sponsored by
Haihe Biopharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Phase 2 study, Pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical UniversityRecruiting
  • Chinese PLA General HospitalRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • The Southwest Hospital of AMURecruiting
  • Sun Yat-sen University Cancer CenterRecruiting
  • The First Affiliated Hospital, Sun Yat-sen UniversityRecruiting
  • The First Affiliated Hospital of Hainan Medical CollegeRecruiting
  • The Third People's Hospital of Hainan ProvinceRecruiting
  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • Hubei Cancer HospitalRecruiting
  • Hunan Cancer HospitalRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Jiangsu Province HospitalRecruiting
  • The People's Hospital Of Guangxi Zhuang Autonomous RegionRecruiting
  • Qingdao Central HospitalRecruiting
  • Obstetrics & Gynecology Hospital of Fudan UniversityRecruiting
  • Shanghai First Maternity and Infant HospitalRecruiting
  • Xiaohua wuRecruiting
  • West China Second University Hospital, Sichuan UniversityRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • Zhongnan Hospital of Wuhan UniversityRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
  • Sir Run Run Shaw Hospital， School of Medicine, Zhejiang UniversityRecruiting
  • Kurume University HospitalRecruiting
  • Osaka University Hospital
  • National Cancer Center HospitalRecruiting
  • Jikei University Hospital
  • Keio University HospitalRecruiting
  • Shikoku Cancer Center
  • Nagoya University HospitalRecruiting
  • Niigata University Medical & Dental Hospital
  • Okayama University HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • Tohoku University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CYH33

Arm Description

40mg daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PFS
PFS by BIRC using RECIST v1.1
OS
OS in each of the PIK3CA mutation status cohort
genetic and protein biomarker alterations
genetic and protein biomarker alterations that can impact PI3K signaling pathway

Full Information

First Posted
August 30, 2021
Last Updated
August 30, 2022
Sponsor
Haihe Biopharma Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05043922
Brief Title
A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haihe Biopharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Recurrent Cancer
Keywords
Phase 2 study, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CYH33
Arm Type
Experimental
Arm Description
40mg daily
Intervention Type
Drug
Intervention Name(s)
CYH33
Intervention Description
a Selective PI3Kα Inhibitor
Primary Outcome Measure Information:
Title
Tumor ORR in patients with PIK3CA hotspot mutations.
Description
Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
PFS
Description
PFS by BIRC using RECIST v1.1
Time Frame
through study completion, an average of 1 year
Title
OS
Description
OS in each of the PIK3CA mutation status cohort
Time Frame
through study completion, an average of 2 year
Title
genetic and protein biomarker alterations
Description
genetic and protein biomarker alterations that can impact PI3K signaling pathway
Time Frame
through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Safety and tolerability
Description
type, incidence, duration, severity and seriousness of adverse events (AEs)
Time Frame
through study completion, an average of 1 year
Title
DLT (Dose Limiting Toxicity) in Japanese patients
Description
Number and proportion of patients who experienced DLT during the first 28-day of treatment in Japanese patients in safety run-in study.
Time Frame
4 weeks
Title
Peak Plasma Concentration (Cmax)
Description
Pharmacokinetics parameters
Time Frame
4weeks
Title
Area under the plasma concentration versus time curve (AUC)
Description
Pharmacokinetics parameters
Time Frame
4weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohua Wu, MD
Phone
+86-21-6417-5590
Email
wu.xh@fudan.eud.cn
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
The Southwest Hospital of AMU
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-sen University Cancer Center
City
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Hainan Medical College
City
Haikou
Country
China
Individual Site Status
Recruiting
Facility Name
The Third People's Hospital of Hainan Province
City
Hainan
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
Country
China
Individual Site Status
Recruiting
Facility Name
Hubei Cancer Hospital
City
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
Hunan Cancer Hospital
City
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Individual Site Status
Recruiting
Facility Name
The People's Hospital Of Guangxi Zhuang Autonomous Region
City
Nanning
Country
China
Individual Site Status
Recruiting
Facility Name
Qingdao Central Hospital
City
Qingdao
Country
China
Individual Site Status
Recruiting
Facility Name
Obstetrics & Gynecology Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai First Maternity and Infant Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Xiaohua wu
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua wu, Director
Phone
+8602164175590
Facility Name
West China Second University Hospital, Sichuan University
City
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital， School of Medicine, Zhejiang University
City
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
National Cancer Center Hospital
City
Chuo Ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kan Yonemori, MD
Facility Name
Jikei University Hospital
City
Minato-Ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shikoku Cancer Center
City
Matsuyama
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Nagoya University Hospital
City
Nagoya
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Okayama University Hospital
City
Okayama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tohoku University Hospital
City
Sendai
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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