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New targeted drug shows promise for tough ovarian cancer

NCT ID NCT05043922

Disease control Sponsor: Haihe Biopharma Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests a drug called CYH33 in 93 women with recurrent ovarian, fallopian tube, or peritoneal clear cell carcinoma that has a specific genetic change (PIK3CA mutation). The drug works by blocking a protein that helps cancer grow. The main goal is to see if it shrinks tumors. Participants must have already tried standard chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CYH33 (a PI3Kα inhibitor)
What this could lead to
If successful, this could provide a new targeted treatment option for people with a hard-to-treat form of ovarian cancer that has returned after standard chemotherapy.
What could go wrong
This is an early-phase trial with only 93 participants, so results may not apply to everyone. The drug may not shrink tumors or could cause side effects like high blood sugar or rash.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

93 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fallopian tube clear cell adenocarcinoma ovarian cancer ovarian clear cell cancer Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer Recurrent cancer

Contacts and locations

Locations

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, China

  • Chinese PLA General Hospital

    Beijing, China

  • Harbin Medical University Cancer Hospital

    Harbin, China

  • Hokkaido University Hospital

    Sapporo, Japan

  • Hubei Cancer Hospital

    Hubei, China

  • Hunan Cancer Hospital

    Hunan, China

  • Jiangsu Province Hospital

    Nanjing, China

  • Jikei University Hospital

    Minato-Ku, Tokyo, Japan

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, Japan

  • Nagoya University Hospital

    Nagoya, Japan

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, Japan

  • Niigata University Medical & Dental Hospital

    Niigata, Japan

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, China

  • Okayama University Hospital

    Okayama, Japan

  • Osaka University Hospital

    Suita, Osaka, Japan

  • Qilu Hospital of Shandong University

    Jinan, China

  • Qingdao Central Hospital

    Qingdao, China

  • Shanghai First Maternity and Infant Hospital

    Shanghai, China

  • Shikoku Cancer Center

    Matsuyama, Japan

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

    Zhejiang, China

  • Sun Yat-sen University Cancer Center

    Guangdong, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, China

  • The First Affiliated Hospital of Hainan Medical College

    Haikou, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangdong, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, China

  • The People's Hospital Of Guangxi Zhuang Autonomous Region

    Nanning, China

  • The Southwest Hospital of AMU

    Chongqing, China

  • The Third People's Hospital of Hainan Province

    Hainan, China

  • Tianjin Medical University General Hospital

    Tianjin, China

  • Tohoku University Hospital

    Sendai, Japan

  • West China Second University Hospital, Sichuan University

    Sichuan, China

  • Xiaohua wu

    Shanghai, China

  • Zhejiang Cancer Hospital

    Hangzhou, China

  • Zhongnan Hospital of Wuhan University

    Wuhan, China

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