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New drug shows promise for rare overgrowth conditions

NCT ID NCT06975618

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 3 times

Summary

This study tests a new drug called CYH33 in people with rare conditions that cause abnormal tissue growth and blood vessel malformations (PROS and PRVM). The trial has two phases: phase I finds the safest dose, and phase II checks if the drug shrinks growths. About 141 adults and adolescents will take part.

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 lead to a new treatment option that shrinks abnormal growths and improves symptoms for people with PROS and PRVM.
What could go wrong
This is an early-phase trial (phase I/II) with a small number of participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to show benefit.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 141 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Dec 2029

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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.

Key inclusion criteria: 1. The patient or the patient's legal guardian (if applicable) voluntarily signs the Informed Consent Form. 2. At the time of signing the informed consent, adult patients should be ≥18 years old (or meet the legal adult age according to local regulations), and adolescent patients should be ≥12 years old and \<18 years old (or meet the legal definition of adolescent according to local regulations; additionally, adolescent patients should weigh ≥35 kg). 3. The patient is diagnosed with PIK3CA-related overgrowth spectrum (PROS) or PIK3CA-related vascular malformations (PRVM), and provides a report confirming PIK3CA mutation detected by local laboratory or the Sponsor-designated central laboratory, with at least one measurable lesion related to PROS or PRVM. 4. Patients should demonstrate adequate organ and bone marrow function during the 28-day screening period. Key exclusion criteria: 1. PROS patients presenting solely with isolated macrodactyly, epidermal nevi/nevus, and megalencephaly (only one clinical feature or any combination of these three features) without other PROS-related lesions. 2. Patients who have received any systemic treatment for PROS or PRVM within 8 weeks prior to the first dose of study drug, or any drug treatment for PROS or PRVM (e.g., mTOR inhibitors) within 28 days prior to the first dose of study drug. 3. Patients who have previously received any PI3K inhibitor treatment.

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Conditions

The condition(s) this trial relates to.

PIK3CA-related overgrowth spectrum

As listed by the trial registrant

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

PIK3CA-related overgrowth spectrum (PROS) PIK3CA-related vascular malformations (PRVM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Capital Center for Children's Health, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Gifu University Hospital

    RECRUITING

    Gifu, 501-1194, Japan

  • Guangzhou Women and Children's Medical Center

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Kyorin University Hospital

    RECRUITING

    Mitaka, Tokyo, 181-8611, Japan

  • National Hospital Organization Kobe Medical Center

    RECRUITING

    Kobe, Hyōgo, 654-0155, Japan

  • Plastic Surgery Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100144, China

  • Shanghai Ninth People Hospital, Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200011, China

  • Shinshu University Hospital

    RECRUITING

    Matsumoto, Nagano, 390-8621, Japan

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410011, China

  • Tohoku University Hospital

    RECRUITING

    Sendai, Miyagi, 980-8574, Japan

  • Tonan Hospital

    RECRUITING

    Sapporo, Hokkaido, 060-0004, Japan

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Yokohama City University Hospital

    RECRUITING

    Yokohama, Kanagawa, 236-0004, Japan

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