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

Last updated: January 3, 2023
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT05372120
ICP-CL-00304
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 orcannot tolerate standard therapy, and with FGF/FGFR gene alteration
  5. Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed orcannot tolerate standard therapy, and with FGF/FGFR gene alteration
  6. At least one measurable lesion as the target lesion at screening assessed according toRECIST V1.1 criteria.

Exclusion

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 oculartoxicity.
  3. Previously or currently endocrine alterations affecting the regulation ofcalcium-phosphorus homeostasis. History and/or current evidence of extensive tissuecalcification.

Study Design

Total Participants: 200
Study Start date:
December 15, 2021
Estimated Completion Date:
June 30, 2024

Connect with a study center

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui 233000
    China

    Active - Recruiting

  • Anhui Provincal Cancer Hospital

    Hefei, Anhui 230031
    China

    Active - Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Active - Recruiting

  • Cancer Hospital.Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • The First Affiliated Hospital of Lanzhou University

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei 50000
    China

    Site Not Available

  • Harbin Medical University cancer hospital

    Harbin, Heilongjiang 150081
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • Henan Tumor Hospital

    Zhengzhou, Henan 450008
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • Union Hospital Toji Medical College Huazhong University of Science and Technology

    WuHan, Hubei 430000
    China

    Active - Recruiting

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Hunan Tumor Hospital

    Changsha, Hunan 410013
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Nantong Cancer Hospital

    Nantong, Jiangsu 226361
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu 214122
    China

    Active - Recruiting

  • The first hospital of jilin University

    Changchun, Jilin 130000
    China

    Active - Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning 110801
    China

    Active - Recruiting

  • QiLu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • Shandong Provincial Institute of Cancer Prevention and Treatment

    Jinan, Shandong 250000
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong 276000
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai 200135
    China

    Active - Recruiting

  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine

    Shanghai, Shanghai 20000
    China

    Active - Recruiting

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • The First Affiliated Hospital of Xi An Jiaotong University

    Xi'an, Shanxi 710061
    China

    Active - Recruiting

  • Sichuan Tumor Hospital

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

  • Second People's Hospital of Yibin City

    Yibin, Sichuan 644000
    China

    Active - Recruiting

  • Tianjin medical university cancer institute&hospital

    Tianjin, Tianjin 300060
    China

    Active - Recruiting

  • Shaoyifu Hospital of Zhejiang University Medical College

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 310014
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.