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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: ICP-723

Detailed Description

Solid Tumors

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rui Hua Xu, MD; Phone Number: 13922296676; Email: xurh@sysucc.org.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • The Second Affiliated Hospital of Anhui Medical University
      • Contact: Mingjun Zhang, MD
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100081
      • Recruiting
      • Peking University Cancer Hospital
      • Contact: Jian Fang, MD
    • Beijing, Beijing Municipality, China, 100081
      • Recruiting
      • The First Medical Center of the Chinese People's Liberation Army General Hospital
      • Contact: Yi Hu, MD
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Contact: Herui Yao, MD
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Cancer Hospital Affiliated to Guangzhou Medical University
      • Contact: Weidong Li, MD
    • Zhuhai, Guangdong, China, 519000
      • Recruiting
      • The Fifth Affiliated Hospital of Sun Yat-sen University
      • Contact: Zhong Lin
      • Contact: Xiaofeng Pei
  • Guangzhou
    • Guangdong, Guangzhou, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: RuiHua XU, MD; Phone Number: 020-87343533; Email: xurh@sysucc.org.cn
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • Shijiazhuang People's Hospital
      • Contact: Jingran Wang, MD
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Cancer Hospital Affiliated to Harbin Medical University
      • Contact: Baogang Liu, MD; Phone Number: 13804552752
  • Henan
    • Luoyang, Henan, China, 471000
      • Recruiting
      • The first affiliated hospital of Henan University of science and technology
      • Contact: Shuangshuang Guo
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Cancer Hospital
      • Contact: Quming Wang, MD
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • The first affiliated hospital of Zhengzhou university
      • Contact: Xingya Li, MD; Phone Number: 15618417071
    • Zhengzhou, Henan, China, 450000
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Shundong Cang, MD; Phone Number: 13592675836
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
      • Contact: Xiaorong Dong, MD; Phone Number: 13986252286
  • Hunan
    • Changsha, Hunan, China, 410000
      • Recruiting
      • Hunan Cancer Hospital
      • Contact: Lin Wu, MD; Phone Number: 13170419973
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Recruiting
      • Jiangsu Provincial People's Hospital
      • Contact: Yongqian Shu, MD
    • Wuxi, Jiangsu, China, 214000
      • Recruiting
      • Affiliated Hospital of Jiangnan University
      • Contact: Yong Mao, MD; Phone Number: 18651581690
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Recruiting
      • The First Affiliated Hospital of NanChang University
      • Contact: Junhe Li, MD; Phone Number: 13699505152
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Affiliated Cancer Hospital of Shandong First Medical University
      • Contact: Zhehai Wang, MD
    • Qingdao, Shandong, China, 266000
      • Recruiting
      • Affiliated Hospital of Qingdao University
      • Contact: Jing Wang, MD
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Recruiting
      • Shanxi Cancer Hospital
      • Contact: Hongxia Lu, MD
  • Yunnan
    • Kunming, Yunnan, China, 650000
      • Recruiting
      • Yunnan Cancer Hospital
      • Contact: Runxiang Yang, MD
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Nong Xu, MD; Phone Number: 0571-87236114
    • Hangzhou, Zhejiang, China, ,310000
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Tao Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICP-723	Drug: ICP-723; ICP-723 is a white, round, uncoated table

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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;	Up to 12 months
MTD	To determine maximum tolerated dose (MTD)	Up to 2 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	To preliminarily obtain pharmacokinetic (PK) data of ICP-723 in the treatment of advanced solid tumors include the peak plasma concentration (Cmax)	Up to 1 month
ORR	Objective Response Rate	Up to 2 months

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2020
• Primary Completion (Estimated): January 25, 2028
• Study Completion (Estimated): February 25, 2028

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ICP-CL-00501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No