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Active, not recruitingNCT05043922Updated Jan 30, 2026

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

A Phase 2 interventional study of CYH33 in Ovarian Cancer and Recurrent Cancer, sponsored by Haihe Biopharma Co., Ltd.. Active, not recruiting at 36 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Haihe Biopharma Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
93
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

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.

Read the 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.

02

Conditions studied

  • Ovarian Cancer
  • Recurrent Cancer

Keywords

  • Phase 2 study
  • Pharmacokinetics
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    CYH33

    40mg daily

    Drug: CYH33

Interventions

  • DrugCYH33

    a Selective PI3Kα Inhibitor

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. PFS

    PFS by BIRC using RECIST v1.1

    Time frame: through study completion, an average of 1 year

  2. OS

    OS in each of the PIK3CA mutation status cohort

    Time frame: through study completion, an average of 2 year

  3. genetic and protein biomarker alterations

    genetic and protein biomarker alterations that can impact PI3K signaling pathway

    Time frame: through study completion, an average of 1 year

Other outcomes

  1. Safety and tolerability

    type, incidence, duration, severity and seriousness of adverse events (AEs)

    Time frame: through study completion, an average of 1 year

  2. 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.

    Time frame: 4 weeks

  3. Peak Plasma Concentration (Cmax)

    Pharmacokinetics parameters

    Time frame: 4weeks

  4. Area under the plasma concentration versus time curve (AUC)

    Pharmacokinetics parameters

    Time frame: 4weeks

06

Study locations

36 sites
  • 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, China
  • Kurume University Hospital
    Kurume, Fukuoka, Japan
  • Osaka University Hospital
    Suita, Osaka, Japan
  • National Cancer Center Hospital
    Chuo Ku, Tokyo, Japan
  • Jikei University Hospital
    Minato-Ku, Tokyo, Japan
  • Keio University Hospital
    Shinjuku-Ku, Tokyo, Japan
  • Shikoku Cancer Center
    Matsuyama, 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
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05043922
Lead sponsor
Haihe Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
Sep 14, 2021
Start date
Oct 11, 2021
Primary completion
Jul 31, 2024
Completion
Feb 28, 2026 (estimated)
Last update
Jan 30, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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