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Ovarian CancerPhase 2NCT05043922

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

A Phase 2 study testing CYH33 in people with Ovarian Cancer and Recurrent Cancer, run by Haihe Biopharma Co., Ltd. at 36 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Recurrent Cancer
What is being tested?
CYH33
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
36 sitesin 2 countries
Study dates
11 Oct 2021to 28 Feb 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

China25 sites

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing

  • Chinese PLA General Hospital

    Beijing

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

  • The Southwest Hospital of AMU

    Chongqing

  • Sun Yat-sen University Cancer Center

    Guangdong

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangdong

  • The First Affiliated Hospital of Hainan Medical College

    Haikou

  • The Third People's Hospital of Hainan Province

    Hainan

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Harbin Medical University Cancer Hospital

    Harbin

  • Hubei Cancer Hospital

    Hubei

  • Hunan Cancer Hospital

    Hunan

  • Qilu Hospital of Shandong University

    Jinan

  • Jiangsu Province Hospital

    Nanjing

  • The People's Hospital Of Guangxi Zhuang Autonomous Region

    Nanning

  • Qingdao Central Hospital

    Qingdao

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai

  • Shanghai First Maternity and Infant Hospital

    Shanghai

  • Xiaohua wu

    Shanghai

  • West China Second University Hospital, Sichuan University

    Sichuan

  • Tianjin Medical University General Hospital

    Tianjin

  • Zhongnan Hospital of Wuhan University

    Wuhan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

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

    Zhejiang

Other trials in China

Japan11 sites

  • National Cancer Center Hospital

    Chuo Ku, Tokyo

  • Kurume University Hospital

    Kurume, Fukuoka

  • Shikoku Cancer Center

    Matsuyama

  • Jikei University Hospital

    Minato-Ku, Tokyo

  • Nagoya University Hospital

    Nagoya

  • Niigata University Medical & Dental Hospital

    Niigata

  • Okayama University Hospital

    Okayama

  • Hokkaido University Hospital

    Sapporo

  • Tohoku University Hospital

    Sendai

  • Keio University Hospital

    Shinjuku-Ku, Tokyo

  • Osaka University Hospital

    Suita, Osaka

Other trials in Japan

About this study

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

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.

Being tested
CYH33
Keywords
Phase 2 study, Pharmacokinetics
Medical subject headings
Ovarian Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CYH33Drug

    a Selective PI3Kα Inhibitor

Study groups in NCT05043922
Study groupRoleWhat they receive
CYH33Experimental40mg daily
Receives: Drug: CYH33

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: through study completion, an average of 1 year

Secondary outcomes (3)

  1. PFS

    PFS by BIRC using RECIST v1.1

    Measured: through study completion, an average of 1 year

  2. OS

    OS in each of the PIK3CA mutation status cohort

    Measured: 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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2021
  2. Study start11 Oct 2021
  3. Primary completion31 Jul 2024
  4. Study completion28 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05043922
Sponsor's protocol ID
CYH33-G201
Status last verified
Jan 2026
First submitted
30 Aug 2021
Last updated
30 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CYH33 in people with Ovarian Cancer and Recurrent Cancer, run by Haihe Biopharma Co., Ltd. at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor ORR in patients with PIK3CA hotspot mutations. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05043922.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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