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

Last updated: January 29, 2026
Sponsor: Haihe Biopharma Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Ovarian Cysts

Pelvic Cancer

Ovarian Cancer

Treatment

CYH33

Clinical Study ID

NCT05043922
CYH33-G201
  • Ages > 18
  • Female

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 Criteria

Inclusion

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 persistentovarian, fallopian tube, or peritoneum clear cell carcinoma.

  4. Patients with recurrent/persistent ovary, fallopian tube or primary peritoneal clearcell 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 ofscreening.

Exclusion

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 theinvestigational product or received local palliative radiation therapy for bonemetastases 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 growthfactors ≤ 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 firstdose 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 Band hepatitis C.

  9. History of acute pancreatitis within 1 year of screening or past medical history ofchronic pancreatitis.

  10. Patients with clinically significant cardiovascular disease

Study Design

Total Participants: 93
Treatment Group(s): 1
Primary Treatment: CYH33
Phase: 2
Study Start date:
October 11, 2021
Estimated Completion Date:
February 28, 2026

Study 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.

Connect with a study center

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Chinese PLA General Hospital

    Beijing,
    China

    Site Not Available

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing 1816670,
    China

    Site Not Available

  • Chinese PLA General Hospital

    Beijing 1816670,
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Active - Recruiting

  • The Southwest Hospital of AMU

    Chongqing,
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing 1814906,
    China

    Site Not Available

  • The Southwest Hospital of AMU

    Chongqing 1814906,
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangdong,
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangdong,
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangdong 7545962,
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangdong 7545962,
    China

    Site Not Available

  • The First Affiliated Hospital of Hainan Medical College

    Haikou,
    China

    Site Not Available

  • The First Affiliated Hospital of Hainan Medical College

    Haikou 1809078,
    China

    Site Not Available

  • The Third People's Hospital of Hainan Province

    Hainan,
    China

    Site Not Available

  • The Third People's Hospital of Hainan Province

    Hainan 1548502,
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou,
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou,
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou 1808926,
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou 1808926,
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin,
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin 2037013,
    China

    Site Not Available

  • Hubei Cancer Hospital

    Hubei,
    China

    Site Not Available

  • Hubei Cancer Hospital

    Hubei 1806951,
    China

    Site Not Available

  • Hubei Cancer Hospital

    Hubei 9801718,
    China

    Site Not Available

  • Hunan Cancer Hospital

    Hunan,
    China

    Site Not Available

  • Hunan Cancer Hospital

    Hunan 1806692,
    China

    Site Not Available

  • Hunan Cancer Hospital

    Hunan 9801714,
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan,
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan 1805753,
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing,
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing 1799962,
    China

    Site Not Available

  • The People's Hospital Of Guangxi Zhuang Autonomous Region

    Nanning,
    China

    Site Not Available

  • The People's Hospital Of Guangxi Zhuang Autonomous Region

    Nanning 1799869,
    China

    Site Not Available

  • Qingdao Central Hospital

    Qingdao,
    China

    Site Not Available

  • Qingdao Central Hospital

    Qingdao 1797929,
    China

    Site Not Available

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai,
    China

    Active - Recruiting

  • Shanghai First Maternity and Infant Hospital

    Shanghai,
    China

    Site Not Available

  • Xiaohua wu

    Shanghai,
    China

    Active - Recruiting

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai 1796236,
    China

    Site Not Available

  • Shanghai First Maternity and Infant Hospital

    Shanghai 1796236,
    China

    Site Not Available

  • Xiaohua wu

    Shanghai 1796236,
    China

    Site Not Available

  • West China Second University Hospital, Sichuan University

    Sichuan,
    China

    Site Not Available

  • West China Second University Hospital, Sichuan University

    Sichuan 7348569,
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin,
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin 1792947,
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan,
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan 1791247,
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an 1790630,
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Zhejiang,
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Zhejiang 10005239,
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Zhejiang 9898779,
    China

    Site Not Available

  • Kurume University Hospital

    Kurume, Fukuoka
    Japan

    Site Not Available

  • Kurume University Hospital

    Kurume 1858088, Fukuoka 1863958
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita, Osaka
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita 1851483, Osaka 1853904
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 1850144
    Japan

    Site Not Available

  • Jikei University Hospital

    Minato-Ku, Tokyo 1850144
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku-Ku, Tokyo 1850144
    Japan

    Site Not Available

  • Shikoku Cancer Center

    Matsuyama,
    Japan

    Site Not Available

  • Shikoku Cancer Center

    Matsuyama 1926099,
    Japan

    Site Not Available

  • Nagoya University Hospital

    Nagoya,
    Japan

    Site Not Available

  • Nagoya University Hospital

    Nagoya 1856057,
    Japan

    Site Not Available

  • Niigata University Medical & Dental Hospital

    Niigata,
    Japan

    Site Not Available

  • Niigata University Medical & Dental Hospital

    Niigata 1855431,
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama,
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama 1854383,
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo,
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo 2128295,
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai,
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai 2111149,
    Japan

    Site Not Available

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