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

NCT ID: NCT04685226

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-27

Study Completion Date

2028-02-25

Brief Summary

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

Detailed Description

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Solid Tumors

Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICP-723

ICP-723

Group Type EXPERIMENTAL

ICP-723

Intervention Type DRUG

ICP-723 is a white, round, uncoated table

Interventions

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ICP-723

ICP-723 is a white, round, uncoated table

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Cancer Hospital Affiliated to Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

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

Guangzhou, Guangdong, China

Site Status RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Site Status RECRUITING

Sun Yat-Sen University Cancer Center

Guangdong, Guangzhou, China

Site Status RECRUITING

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China

Site Status RECRUITING

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

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

Wuhan, Hubei, China

Site Status RECRUITING

Hunan Cancer hospital

Changsha, Hunan, China

Site Status RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Site Status RECRUITING

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status RECRUITING

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, China

Site Status RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

The first affiliated hospital Zhejiang university school of medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rui Hua Xu, MD

Role: CONTACT

13922296676

Facility Contacts

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Mingjun Zhang, MD

Role: primary

Jian Fang, MD

Role: primary

Yi Hu, MD

Role: primary

Weidong Li, MD

Role: primary

Herui Yao, MD

Role: primary

Zhong Lin

Role: primary

Xiaofeng Pei

Role: backup

RuiHua XU, MD

Role: primary

020-87343533

Jingran Wang, MD

Role: primary

Baogang Liu, MD

Role: primary

13804552752

Shuangshuang Guo

Role: primary

Quming Wang, MD

Role: primary

Shundong Cang, MD

Role: primary

13592675836

Xingya Li, MD

Role: primary

15618417071

Xiaorong Dong, MD

Role: primary

13986252286

Lin Wu, MD

Role: primary

13170419973

Yongqian Shu, MD

Role: primary

Yong Mao, MD

Role: primary

18651581690

Junhe Li, MD

Role: primary

13699505152

Zhehai Wang, MD

Role: primary

Jing Wang, MD

Role: primary

Hongxia Lu, MD

Role: primary

Runxiang Yang, MD

Role: primary

Tao Li, MD

Role: primary

Nong Xu, MD

Role: primary

0571-87236114

Other Identifiers

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ICP-CL-00501

Identifier Type: -

Identifier Source: org_study_id

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