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Experimental pill ICP-723 enters human trials for Hard-to-Treat cancers

NCT ID NCT04685226

Disease control Sponsor: Beijing InnoCare Pharma Tech 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests an experimental oral drug called ICP-723 in people with advanced solid tumors that cannot be removed by surgery. The trial includes both adults and adolescents (ages 12 and up). The main goals are to check the drug's safety, find the best dose, and see if it can shrink tumors. About 310 participants will take part across multiple centers.

What this could mean

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

Active substance
ICP-723 (an experimental oral tablet)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that are hard to treat.
What could go wrong
This is an early-phase trial (Phase I/II) focused on safety and dosing, so it is not yet known if ICP-723 will effectively shrink tumors or improve survival. Side effects are possible and being closely monitored.

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 310 people

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

Started

Sep 2020

Expected to finish

Feb 2028

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

12 years and older

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.

Inclusion Criteria: 1. Histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (CNS) tumors.. 2. Age: Adult Cohort: Age ≥ 18 years; Adolescent cohort: 12 ≤ years \< 18 years. 3. At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria. 4. Adult cohort: ECOG PS score of 0-1; 5. Adolescent cohort: Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) PS score \> 60. 6. Life expectancy \> 3 months. 7. Female patients or male patients of childbearing potential, who agree to use medically acceptable effective methods of birth control throughout the study up to 12 weeks after the last dose of the study treatment. 8. Patients who have signed the Informed Consent Form voluntarily and agree to follow the therapeutic regimen and the visit schedule. Exclusion Criteria: 1. Any other active malignancy within 5 years prior to the first dose of the study drug. 2. Prior anti-cancer treatment within 28 days prior to the first dose. 3. Major surgical procedures within 4 weeks or minor surgical procedures within 2 weeks prior to the first dose of the study drug. 4. A history of allergic disease, severe drug allergy, known hypersensitivity to any component of the ICP-723 tablet formulation. 5. Other situations that, in the investigator's opinion, would make the subject unsuitable for participation in the study. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Solid tumors

How to take part

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

  1. The places running it

    24 sites. 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

  • Affiliated Cancer Hospital of Shandong First Medical University

    RECRUITING

    Jinan, Shandong, China

  • Affiliated Hospital of Jiangnan University

    RECRUITING

    Wuxi, Jiangsu, 214000, China

  • Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, 266000, China

  • Cancer Hospital Affiliated to Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Cancer Hospital Affiliated to Harbin Medical University

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Hunan Cancer hospital

    RECRUITING

    Changsha, Hunan, 410000, China

  • Jiangsu Provincial People's Hospital

    RECRUITING

    Nanjing, Jiangsu, 210000, China

  • Peking University Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100081, China

  • Shanxi Cancer Hospital

    RECRUITING

    Taiyuan, Shanxi, 030000, China

  • Shijiazhuang People's Hospital

    RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Sun Yat-Sen University Cancer Center

    RECRUITING

    Guangdong, Guangzhou, 510060, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Zhuhai, Guangdong, 519000, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, 471000, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330000, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • The First Medical Center of the Chinese People's Liberation Army General Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100081, China

  • The Second Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230000, China

  • The first affiliated hospital Zhejiang university school of medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430000, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, Yunnan, 650000, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, Zhejiang, ,310000, China

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