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

NCT ID: NCT05372120

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICP-192

20 mg once daily

Group Type EXPERIMENTAL

ICP-192

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing InnoCare Pharma Tech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ye Guo

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

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The first affiliated hospital of bengbu medical college

Bengbu, Anhui, China

Site Status RECRUITING

Anhui Provincal Cancer Hospital

Hefei, Anhui, China

Site Status RECRUITING

Cancer Hospital.Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status ACTIVE_NOT_RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

The First Affiliated Hospital of Lanzhou University

Lanzhou, Gansu, China

Site Status NOT_YET_RECRUITING

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status NOT_YET_RECRUITING

Harbin Medical University cancer hospital

Harbin, Heilongjiang, China

Site Status NOT_YET_RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Henan Tumor Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Union Hospital Toji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, China

Site Status NOT_YET_RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

Site Status NOT_YET_RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status NOT_YET_RECRUITING

Hunan Tumor Hospital

Changsha, Hunan, China

Site Status RECRUITING

Nantong Cancer Hospital

Nantong, Jiangsu, China

Site Status RECRUITING

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Site Status RECRUITING

The first hospital of jilin University

Changchun, Jilin, China

Site Status RECRUITING

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Site Status RECRUITING

Shandong Provincial Institute of Cancer Prevention and Treatment

Jinan, Shandong, China

Site Status RECRUITING

QiLu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, China

Site Status RECRUITING

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status NOT_YET_RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

The First Affiliated Hospital of Xi An Jiaotong University

Xi’an, Shanxi, China

Site Status RECRUITING

Sichuan Tumor Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Second People's Hospital of Yibin City

Yibin, Sichuan, China

Site Status RECRUITING

Tianjin medical university cancer institute&hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Shaoyifu Hospital of Zhejiang University Medical College

Hangzhou, Zhejiang, China

Site Status NOT_YET_RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ye Guo

Role: CONTACT

13501678472

Facility Contacts

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Jiang Hao

Role: primary

Yifu He

Role: primary

Yan Sun

Role: primary

Shaojun Lin

Role: primary

Juntao Ran

Role: primary

Ting Wang

Role: backup

Weidong Li

Role: primary

Qingqing Cai

Role: primary

Xiaoying Xue

Role: primary

Tongsen Zheng

Role: primary

Shundong Cang

Role: primary

Xingya Li

Role: primary

Suxia Luo

Role: primary

Yanru Qin

Role: primary

Kunyu Yang

Role: primary

Hu Guangyuan

Role: primary

Liaoyang Shen

Role: primary

Zhenyang Liu

Role: primary

Cuihong Jiang

Role: primary

Lei Yang

Role: primary

Yong Mao

Role: primary

Jiujiang Cui

Role: primary

Bin Hu

Role: primary

Man Hu

Role: primary

Yufeng Cheng

Role: primary

Jianhua Shi

Role: primary

Guipei Zhu

Role: primary

Tianshu Liu

Role: primary

Ye Guo

Role: primary

Shaoqiang Zhang

Role: primary

Shichuan Zhang

Role: primary

Nianyong Chen

Role: primary

Kaijian Lei

Role: primary

Peiguo Wang

Role: primary

Hongming Pan

Role: primary

Meiyu Fang

Role: primary

Minghua Ge

Role: primary

Other Identifiers

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ICP-CL-00304

Identifier Type: -

Identifier Source: org_study_id

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