A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
- Registration Number
- NCT05372120
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Signed the ICF and Age ≥ 18 years old, either sex.
- ECOG ≤ 1.
- Life expectancy of at least 3 months.
- 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
- 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
- At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
- Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICP-192 ICP-192 20 mg once daily
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) From the time of first dose until objective disease progression, an average of 6 months 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).
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) From the time of first dose until objective disease progression, an average of 6 months 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
Disease Control Rate (DCR) From the time of first dose until objective disease progression, an average of 6 months 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).
Trial Locations
- Locations (36)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Cancer Hospital.Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
The first affiliated hospital of bengbu medical college
🇨🇳Bengbu, Anhui, China
Anhui Provincal Cancer Hospital
🇨🇳Hefei, Anhui, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Harbin Medical University cancer hospital
🇨🇳Harbin, Heilongjiang, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Henan Tumor Hospital
🇨🇳Zhengzhou, Henan, China
Union Hospital Toji Medical College Huazhong University of Science and Technology
🇨🇳WuHan, Hubei, China
Tongji Hospital Tongji Medical College of HUST
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Hunan Tumor Hospital
🇨🇳Changsha, Hunan, China
Nantong Cancer Hospital
🇨🇳Nantong, Jiangsu, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, Jiangsu, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
QiLu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Linyi Cancer Hospital
🇨🇳Linyi, Shandong, China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Xi An Jiaotong University
🇨🇳Xi'an, Shanxi, China
Zhongshan Hospital Affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai East Hospital
🇨🇳Shanghai, Shanghai, China
Sichuan Tumor Hospital
🇨🇳Chengdu, Sichuan, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Second People's Hospital of Yibin City
🇨🇳Yibin, Sichuan, China
Shaoyifu Hospital of Zhejiang University Medical College
🇨🇳Hangzhou, Zhejiang, China
Tianjin medical university cancer institute&hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The first hospital of jilin University
🇨🇳Changchun, Jilin, China
Shandong Provincial Institute of Cancer Prevention and Treatment
🇨🇳Jinan, Shandong, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China