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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: ICP-192

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ye Guo; Phone Number: 13501678472; Email: pattrickguo@gmail.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233000
      • Recruiting
      • The First Affiliated Hospital of Bengbu Medical College
      • Contact: Jiang Hao
    • Hefei, Anhui, China, 230031
      • Recruiting
      • Anhui Provincal Cancer Hospital
      • Contact: Yifu He
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Contact: Yan Sun
    • Beijing, Beijing, China, 100021
      • Active, not recruiting
      • Cancer Hospital.Chinese Academy of Medical Sciences
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: Shaojun Lin
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Not yet recruiting
      • The First Affiliated Hospital of Lanzhou University
      • Contact: Juntao Ran
      • Contact: Ting Wang
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen University Cancer Center
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Affiliated Cancer Hospital and institute of Guangzhou Medical University
      • Contact: Weidong Li
  • Hebei
    • Shijiazhuang, Hebei, China, 50000
      • Not yet recruiting
      • The Second Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Not yet recruiting
      • Harbin medical university cancer hospital
      • Contact: Tongsen Zheng
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The first affiliated hospital of Zhengzhou university
    • Zhengzhou, Henan, China, 450008
      • Not yet recruiting
      • Henan Tumor Hospital
    • Zhengzhou, Henan, China, 450003
      • Not yet recruiting
      • Henan Provincial People's Hospital
      • Contact: Shundong Cang
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • The first affiliated hospital of Zhengzhou university
      • Contact: Xingya Li
  • Hubei
    • WuHan, Hubei, China, 430000
      • Recruiting
      • Union Hospital Toji Medical College Huazhong University of Science and Technology
      • Contact: Kunyu Yang
    • Wuhan, Hubei, China, 430030
      • Not yet recruiting
      • Tongji Hospital Tongji Medical College Of Hust
      • Contact: Hu Guangyuan
  • Hunan
    • Changsha, Hunan, China, 410013
      • Not yet recruiting
      • Hunan Cancer Hospital
      • Contact: Zhenyang Liu
    • Changsha, Hunan, China, 410008
      • Not yet recruiting
      • Xiangya Hospital Central South University
      • Contact: Liaoyang Shen
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Tumor Hospital
      • Contact: Cuihong Jiang
  • Jiangsu
    • Nantong, Jiangsu, China, 226361
      • Recruiting
      • Nantong Cancer Hospital
    • Wuxi, Jiangsu, China, 214122
      • Recruiting
      • Affiliated Hospital of Jiangnan University
      • Contact: Yong Mao
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • The First Hospital of Jilin University
      • Contact: Jiujiang Cui
  • Liaoning
    • Shenyang, Liaoning, China, 110801
      • Recruiting
      • Liaoning Cancer Hospital & Institute
      • Contact: Bin Hu
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Yufeng Cheng
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Shandong Provincial Institute of Cancer Prevention and Treatment
      • Contact: Man Hu
    • Linyi, Shandong, China, 276000
      • Recruiting
      • Linyi Cancer Hospital
      • Contact: Jianhua Shi
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Not yet recruiting
      • Zhongshan Hospital Affiliated to Fudan University
    • Shanghai, Shanghai, China, 20000
      • Recruiting
      • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine
      • Contact: Guipei Zhu
    • Shanghai, Shanghai, China, 200135
      • Recruiting
      • Shanghai East Hospital
      • Contact: Ye Guo
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • Recruiting
      • The First Affiliated Hospital of Xi An JiaoTong University
      • Contact: Shaoqiang Zhang
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • West China Hospital, Sichuan University
      • Contact: Nianyong Chen
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • Sichuan Tumor Hospital
      • Contact: Shichuan Zhang
    • Yibin, Sichuan, China, 644000
      • Recruiting
      • Second People's Hospital of Yibin City
      • Contact: Kaijian Lei
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute&Hospital
      • Contact: Peiguo Wang
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Minghua Ge
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Meiyu Fang
    • Hangzhou, Zhejiang, China, 310000
      • Not yet recruiting
      • Shaoyifu Hospital of Zhejiang University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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-192; 20 mg once daily	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
• Investigators: Principal Investigator: Ye Guo, Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: May 8, 2022
• First Submitted That Met QC Criteria: May 8, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ICP-CL-00304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No