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

Last updated: August 30, 2022
Sponsor: Haihe Biopharma Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Ovarian Cancer

Pelvic Cancer

Vaginal Cancer

Treatment

N/A

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: 86
Study Start date:
August 13, 2021
Estimated Completion Date:
June 30, 2023

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

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Active - Recruiting

  • The Southwest Hospital of AMU

    Chongqing,
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangdong,
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangdong,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Hainan Medical College

    Haikou,
    China

    Active - Recruiting

  • The Third People's Hospital of Hainan Province

    Hainan,
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou,
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou,
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin,
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Hubei,
    China

    Active - Recruiting

  • Hunan Cancer Hospital

    Hunan,
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan,
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing,
    China

    Active - Recruiting

  • The People's Hospital Of Guangxi Zhuang Autonomous Region

    Nanning,
    China

    Active - Recruiting

  • Qingdao Central Hospital

    Qingdao,
    China

    Active - Recruiting

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai,
    China

    Active - Recruiting

  • Shanghai First Maternity and Infant Hospital

    Shanghai,
    China

    Active - Recruiting

  • Xiaohua wu

    Shanghai,
    China

    Active - Recruiting

  • West China Second University Hospital, Sichuan University

    Sichuan,
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin,
    China

    Active - Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Active - Recruiting

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

    Zhejiang,
    China

    Active - Recruiting

  • Kurume University Hospital

    Kurume, Fukuoka
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita, Osaka
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo Ku, Tokyo
    Japan

    Active - Recruiting

  • Jikei University Hospital

    Minato-Ku, Tokyo
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku-Ku, Tokyo
    Japan

    Active - Recruiting

  • Shikoku Cancer Center

    Matsuyama,
    Japan

    Site Not Available

  • Nagoya University Hospital

    Nagoya,
    Japan

    Active - Recruiting

  • Niigata University Medical & Dental Hospital

    Niigata,
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama,
    Japan

    Active - Recruiting

  • Hokkaido University Hospital

    Sapporo,
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai,
    Japan

    Active - Recruiting

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