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Solid TumorsPhase 1/2NCT04685226

A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors

A Phase 1/2 study testing ICP-723 in people with Solid Tumors, run by Beijing InnoCare Pharma Tech Co., Ltd. at 24 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A Multicenter, Nonrandomized, Open-Label Phase I/IIClinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Solid Tumors Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Solid Tumors
What is being tested?
ICP-723
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
24 sitesChina
Study dates
27 Sep 2020to 25 Feb 2028
Phase
Phase 1/2
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histopathologically confirmed surgically unresectable locally advanced or metastatic solid tumors or primary central nervous system (CNS) tumors..
  • Age:
  • Adult Cohort: Age ≥ 18 years; Adolescent cohort: 12 ≤ years < 18 years.
  • 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.
  • Adult cohort: ECOG PS score of 0-1;
  • Adolescent cohort: Karnofsky (age ≥ 16 years) or Lansky (age < 16 years) PS score > 60.
Show all 9Show fewer
  • Life expectancy > 3 months.
  • 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.
  • Patients who have signed the Informed Consent Form voluntarily and agree to follow the therapeutic regimen and the visit schedule.

Who cannot join

  • Any other active malignancy within 5 years prior to the first dose of the study drug.
  • Prior anti-cancer treatment within 28 days prior to the first dose.
  • Major surgical procedures within 4 weeks or minor surgical procedures within 2 weeks prior to the first dose of the study drug.
  • A history of allergic disease, severe drug allergy, known hypersensitivity to any component of the ICP-723 tablet formulation.
  • 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.

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rui Hua Xu, MD contact

13922296676

xurh@sysucc.org.cn

24 sites in 1 country

China24 sites, 24 recruiting

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100081

    Jian Fang, MD

    Recruiting

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

    Beijing, Beijing Municipality, 100081

    Yi Hu, MD

    Recruiting

  • Hunan Cancer hospital

    Changsha, Hunan, 410000

    Lin Wu, MD, 13170419973

    Recruiting

  • Sun Yat-Sen University Cancer Center

    Guangdong, Guangzhou, 510060

    RuiHua XU, MD, 020-87343533, xurh@sysucc.org.cn

    Recruiting

  • Cancer Hospital Affiliated to Guangzhou Medical University

    Guangzhou, Guangdong, 510000

    Weidong Li, MD

    Recruiting

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

    Guangzhou, Guangdong, 510000

    Herui Yao, MD

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, ,310000

    Tao Li, MD

    Recruiting

  • The first affiliated hospital Zhejiang university school of medicine

    Hangzhou, Zhejiang, 310003

    Nong Xu, MD, 0571-87236114

    Recruiting

  • Cancer Hospital Affiliated to Harbin Medical University

    Harbin, Heilongjiang, 150000

    Baogang Liu, MD, 13804552752

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

    Mingjun Zhang, MD

    Recruiting

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, Shandong

    Zhehai Wang, MD

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650000

    Runxiang Yang, MD

    Recruiting

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

    Luoyang, Henan, 471000

    Shuangshuang Guo

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Junhe Li, MD, 13699505152

    Recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210000

    Yongqian Shu, MD

    Recruiting

  • Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

    Jing Wang, MD

    Recruiting

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei, 050000

    Jingran Wang, MD

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

    Hongxia Lu, MD

    Recruiting

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

    Wuhan, Hubei, 430000

    Xiaorong Dong, MD, 13986252286

    Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214000

    Yong Mao, MD, 18651581690

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Quming Wang, MD

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

    Shundong Cang, MD, 13592675836

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Xingya Li, MD, 15618417071

    Recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Zhong Lin

    Xiaofeng Pei

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Nonrandomized, Open-Label Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Solid Tumors

A Multicenter, Nonrandomized, Open-Label Phase I/IIClinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Solid Tumors

Read the detailed description

Solid Tumors

Conditions
Solid Tumors
Being tested
ICP-723

What participants receive

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

  • ICP-723Drug

    ICP-723 is a white, round, uncoated table

Study groups in NCT04685226
Study groupRoleWhat they receive
ICP-723ExperimentalICP-723
Receives: Drug: ICP-723

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    To evaluate the safety and tolerability of ICP-723 at different doses in the treatment of advanced solid tumors;

    Measured: Up to 12 months

  2. MTD

    To determine maximum tolerated dose (MTD)

    Measured: Up to 2 Months

Secondary outcomes (2)

  1. Cmax

    To preliminarily obtain pharmacokinetic (PK) data of ICP-723 in the treatment of advanced solid tumors include the peak plasma concentration (Cmax)

    Measured: Up to 1 month

  2. ORR

    Objective Response Rate

    Measured: Up to 2 months

Timeline

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

  1. First posted28 Dec 2020
  2. Study start27 Sep 2020
  3. Primary completion25 Jan 2028 (estimated)
  4. Study completion25 Feb 2028 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685226
Sponsor's protocol ID
ICP-CL-00501
Status last verified
Aug 2025
First submitted
22 Dec 2020
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICP-723 in people with Solid Tumors, run by Beijing InnoCare Pharma Tech Co., Ltd. at 24 sites in China.

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

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Rui Hua Xu, MD (13922296676, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 12 months). The study lists 2 primary outcomes in all. 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 NCT04685226.

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 2 Sep 2025.

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