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

January 29, 2026 updated by: Haihe Biopharma Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Chinese PLA General Hospital
      • Beijing, China
        • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
      • Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
      • Chongqing, China
        • The Southwest Hospital of Amu
      • Guangdong, China
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangdong, China
        • Sun Yat-Sen University Cancer Center
      • Haikou, China
        • The First Affiliated Hospital Of Hainan Medical College
      • Hainan, China
        • The Third People's Hospital of Hainan Province
      • Hangzhou, China
        • Zhejiang Cancer Hospital
      • Hangzhou, China
        • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Harbin, China
        • Harbin Medical University Cancer Hospital
      • Hubei, China
        • Hubei Cancer Hospital
      • Hunan, China
        • Hunan Cancer Hospital
      • Jinan, China
        • Qilu Hospital of Shandong University
      • Nanjing, China
        • Jiangsu Province Hospital
      • Nanning, China
        • The People's Hospital Of Guangxi Zhuang Autonomous Region
      • Qingdao, China
        • Qingdao Central Hospital
      • Shanghai, China
        • Shanghai First Maternity and Infant Hospital
      • Shanghai, China
        • Obstetrics & Gynecology Hospital of Fudan University
      • Shanghai, China
        • Xiaohua wu
      • Sichuan, China
        • West China Second University Hospital, Sichuan University
      • Tianjin, China
        • Tianjin Medical University General Hospital
      • Wuhan, China
        • Zhongnan Hospital of Wuhan University
      • Xi'an, China
        • The First Affiliated Hospital Of Xi'an Jiaotong University
      • Zhejiang, China
        • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
  • Japan
      • Matsuyama, Japan
        • Shikoku Cancer Center
      • Nagoya, Japan
        • Nagoya University Hospital
      • Niigata, Japan
        • Niigata University Medical & Dental Hospital
      • Okayama, Japan
        • Okayama University Hospital
      • Sapporo, Japan
        • Hokkaido University Hospital
      • Sendai, Japan
        • Tohoku University Hospital
    • Fukuoka
      • Kurume, Fukuoka, Japan
        • Kurume University Hospital
    • Osaka
      • Suita, Osaka, Japan
        • Osaka University Hospital
    • Tokyo
      • Chuo Ku, Tokyo, Japan
        • National Cancer Center Hospital
      • Minato-Ku, Tokyo, Japan
        • Jikei University Hospital
      • Shinjuku-Ku, Tokyo, Japan
        • Keio university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CYH33
40mg daily
Drug: CYH33
a Selective PI3Kα Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor ORR in patients with PIK3CA hotspot mutations.
Time Frame: 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: through study completion, an average of 1 year
PFS by BIRC using RECIST v1.1
through study completion, an average of 1 year
OS
Time Frame: through study completion, an average of 2 year
OS in each of the PIK3CA mutation status cohort
through study completion, an average of 2 year
genetic and protein biomarker alterations
Time Frame: through study completion, an average of 1 year
genetic and protein biomarker alterations that can impact PI3K signaling pathway
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability
Time Frame: through study completion, an average of 1 year
type, incidence, duration, severity and seriousness of adverse events (AEs)
through study completion, an average of 1 year
DLT (Dose Limiting Toxicity) in Japanese patients
Time Frame: 4 weeks
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
Peak Plasma Concentration (Cmax)
Time Frame: 4weeks
Pharmacokinetics parameters
4weeks
Area under the plasma concentration versus time curve (AUC)
Time Frame: 4weeks
Pharmacokinetics parameters
4weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haihe Biopharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2021

Primary Completion (Actual)

July 31, 2024

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 14, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYH33-G201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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