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

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04685226
• Other study ID #: ICP-CL-00501
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

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