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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04685226
Other study ID # ICP-CL-00501
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 27, 2020
Est. completion date February 2028

Study information

Verified date February 2024
Source Beijing InnoCare Pharma Tech Co., Ltd.
Contact Rui Hua Xu, MD
Phone 13922296676
Email xurh@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Description:

Solid Tumors


Recruitment information / eligibility

Status Recruiting
Enrollment 310
Est. completion date February 2028
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
ICP-723
ICP-723 is a white, round, uncoated table

Locations

Country Name City State
China Peking University Cancer Hospital Beijing Beijing
China The First Medical Center of the Chinese People's Liberation Army General Hospital Beijing Beijing
China Hunan Cancer hospital Changsha Hunan
China Sun Yat-Sen University Cancer Center Guangdong Guangzhou
China Cancer Hospital Affiliated to Guangzhou Medical University Guangzhou Guangdong
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong
China Cancer Hospital Affiliated to Harbin Medical University Ha'erbin Heilongjiang
China The first affiliated hospital Zhejiang university school of medicine Hangzhou Zhejiang
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China The Second Affiliated Hospital of Anhui Medical University Hefei Anhui
China Affiliated Cancer Hospital of Shandong First Medical University Jinan Shandong
China Yunnan Cancer Hospital Kunming Yunnan
China The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Jiangsu Provincial People's Hospital Nanjing Jiangsu
China Affiliated Hospital of Qingdao University Qingdao Shandong
China Shijiazhuang People's Hospital Shijiazhuang Hebei
China Shanxi Cancer Hospital Taiyuan Shanxi
China Union Hospital, Tongji Medical College,Huazhong University of Science and Technology Wuhan Hubei
China Affiliated Hospital of Jiangnan University Wuxi Jiangsu
China Henan Cancer Hospital Zhengzhou Henan
China Henan Provincial People's Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
China The Fifth Affiliated Hospital of Sun Yat-sen University Zhuhai Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Beijing InnoCare Pharma Tech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary MTD To determine maximum tolerated dose (MTD) Up to 2 Months
Secondary 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
Secondary ORR Objective Response Rate Up to 2 months
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