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
1 other identifier
interventional
200
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2021
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2021
CompletedFirst Submitted
Initial submission to the registry
May 8, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedJanuary 4, 2023
December 1, 2022
2 years
May 8, 2022
January 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Duration of response (DOR)
From the time of first dose until objective disease progression, an average of 6 months
Disease Control Rate (DCR)
From the time of first dose until objective disease progression, an average of 6 months
Other Outcomes (2)
Progression Free Survival (PFS)
From the time of first dose until objective disease progression, an average of 6 months
Overall survival (OS)
From the time of first dose until objective disease progression, an average of 1 year
Study Arms (1)
ICP-192
EXPERIMENTAL20 mg once daily
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233000, China
Anhui Provincal Cancer Hospital
Hefei, Anhui, 230031, China
Cancer Hospital.Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
The First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50000, China
Harbin Medical University cancer hospital
Harbin, Heilongjiang, 150081, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450003, China
Henan Tumor Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital Toji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Hunan Tumor Hospital
Changsha, Hunan, 410013, China
Nantong Cancer Hospital
Nantong, Jiangsu, 226361, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214122, China
The first hospital of jilin University
Changchun, Jilin, 130000, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801, China
Shandong Provincial Institute of Cancer Prevention and Treatment
Jinan, Shandong, 250000, China
QiLu Hospital of Shandong University
Jinan, Shandong, 250012, China
Linyi Cancer Hospital
Linyi, Shandong, 276000, China
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School Medicine
Shanghai, Shanghai Municipality, 20000, China
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200135, China
The First Affiliated Hospital of Xi An Jiaotong University
Xi’an, Shanxi, 710061, China
Sichuan Tumor Hospital
Chengdu, Sichuan, 610000, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000, China
Second People's Hospital of Yibin City
Yibin, Sichuan, 644000, China
Tianjin medical university cancer institute&hospital
Tianjin, Tianjin Municipality, 300060, China
Shaoyifu Hospital of Zhejiang University Medical College
Hangzhou, Zhejiang, 310000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Study Officials
- PRINCIPAL INVESTIGATOR
Ye Guo
Shanghai East Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2022
First Posted
May 12, 2022
Study Start
December 15, 2021
Primary Completion
December 31, 2023
Study Completion
June 30, 2024
Last Updated
January 4, 2023
Record last verified: 2022-12