A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations

Advanced Solid Tumor Clinical Trial

Official title:

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372120
• Other study ID #: ICP-CL-00304
• Status: Recruiting
• Phase: Phase 2
• Start date: December 15, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2022
• Source: Beijing InnoCare Pharma Tech Co., Ltd.
• Contact: Ye Guo
• Phone: 13501678472
• Email: pattrickguo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed the ICF and Age = 18 years old, either sex.

2. ECOG = 1.

3. Life expectancy of at least 3 months.

4. Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration

5. Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration

6. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.

Exclusion Criteria:

1. Prior treatment with selective FGFR inhibitors or FGFR antibodies.

2. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.

3. Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• ICP-192
ICP-192 is a round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital.Chinese Academy of Medical Sciences	Beijing	Beijing
China	The first affiliated hospital of bengbu medical college	Bengbu	Anhui
China	The first hospital of jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Hunan Tumor Hospital	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Sichuan Tumor Hospital	Chengdu	Sichuan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Affiliated Cancer Hospital and Institute of Guangzhou Medical University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Shaoyifu Hospital of Zhejiang University Medical College	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Harbin Medical University cancer hospital	Harbin	Heilongjiang
China	Anhui Provincal Cancer Hospital	Hefei	Anhui
China	QiLu Hospital of Shandong University	Jinan	Shandong
China	Shandong Provincial Institute of Cancer Prevention and Treatment	Jinan	Shandong
China	The First Affiliated Hospital of Lanzhou University	Lanzhou	Gansu
China	Linyi Cancer Hospital	Linyi	Shandong
China	Nantong Cancer Hospital	Nantong	Jiangsu
China	Shanghai East Hospital	Shanghai	Shanghai
China	Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine	Shanghai	Shanghai
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin medical university cancer institute&hospital	Tianjin	Tianjin
China	Tongji Hospital Tongji Medical College of HUST	Wuhan	Hubei
China	Union Hospital Toji Medical College Huazhong University of Science and Technology	WuHan	Hubei
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xi An Jiaotong University	Xi'an	Shanxi
China	Second People's Hospital of Yibin City	Yibin	Sichuan
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	Henan Tumor Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

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
Other	Progression Free Survival (PFS)	Progression free survival is the time period from start of study medication till the disease progression or death, whichever occurs first.	From the time of first dose until objective disease progression, an average of 6 months
Other	Overall survival (OS)	OS is the time period from start of study medication untill death from any cause.	From the time of first dose until objective disease progression, an average of 1 year
Primary	Objective response rate (ORR)	ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).	From the time of first dose until objective disease progression, an average of 6 months
Secondary	Duration of response (DOR)	DOR is time interval from the first date that criteria for complete response or partial response are met to the first date of progression of disease	From the time of first dose until objective disease progression, an average of 6 months
Secondary	Disease Control Rate (DCR)	DCR based on assessment of confirmed Complete response (CR), partial response (PR) or stable disease(SD) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).	From the time of first dose until objective disease progression, an average of 6 months