Trial Title:
A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
NCT ID:
NCT05678270
Condition:
Intrahepatic Cholangiocarcinoma (ICC)
Conditions: Official terms:
Cholangiocarcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ICP-192
Description:
ICP-192 is a round, uncoated tablet, 5mg, orally.
Arm group label:
ICP-192
Summary:
This is a single-arm, open-label, multi-center phase 2 clinical trial of ICP-192. The
purpose of this study is to evaluate the efficacy and safety in patients with
FGFR2-Rearranged unresectable or metastatic intrahepatic cholangiocarcinoma who failed
prior therapy
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed the ICF and Age ≥ 18 years old, either sex.
2. ECOG score of 0-1.
3. Life expectancy > 3 months.
4. Histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma
with unresectable, recurrent or metastatic (AJCC 2017, 8th edition, TNM stage IV)
tumor that has progressed following at least one line of chemotherapy and
progression/recurrence within 6 months after neoadjuvant/adjuvant chemotherapy may
be included.
5. FGFR2 fusion /rearrangement as confirmed by the central laboratory.
6. At least one measurable lesion at screening as target lesion per RECIST 1.1.
7. Organ functions meeting the protocol requirements.
8. Contraception according to the protocol requirements.
Exclusion Criteria:
1. Presence of other malignancies requiring medical intervention.
2. Prior treatment with selective FGFR inhibitors or FGFR antibodies.
3. Treatment with biological products, radical radiotherapy, and other investigational
drugs within 4 weeks prior to the first dose of study drug. Chemotherapy within 3
weeks prior to the first dose of study drug.
4. Known symptomatic central nervous system (CNS) metastases.
5. Patients who have not recovered from the toxicity caused by previous anti-tumor
treatment and have ≥ Grade 2 adverse events (judged per CTCAE V5.0 evaluation
criterion) at the first dose of study drug.
6. Currently uncontrolled cardiovascular and cerebrovascular diseases, or a past
medical history.
7. Any unstable or uncontrolled systemic disease as judged by the investigator, such
as: active infection requiring intravenous therapy, uncontrolled hypertension (After
treatment systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90
mmHg), and diabetes mellitus (HbA1c > 8%).
8. Current active bleeding, such as deep venous thrombosis, portal hypertension signs
leading to gastroesophageal venous bleeding.
9. Wound with active infection.
10. Major surgical procedures within 4 weeks prior to the first dose of the study drug
or minor surgical procedures within 2 weeks prior to the first dose of the study
drug.
11. Any corneal or retinal abnormalities that may result in an increased risk of ocular
toxicity
12. History and/or current evidence of extensive tissue calcification, including but not
limited to calcification in soft tissues, kidney, intestine, myocardium, vasculature
and/or the lungs, with the exception of lymph node calcification, mild pulmonary
parenchymal calcification, and asymptomatic coronary artery calcification.
13. Clinically serious gastrointestinal dysfunction that may affect the intake,
transport or absorption of the study drug (such as poorly controlled nausea,
vomiting, diarrhea; malabsorption syndrome; intestinal obstruction and small bowel
resection, etc.), or the patient was unable to swallow the drug orally.
14. Active HBV infection, Active HCV infection, HIV infection.
15. Female subjects who are pregnant or breastfeeding, or plan to have a pregnancy
within 6 months after the last dose of the study drug; or male subjects who plan to
father a child during the study or within 6 months after the last dose of the study
drug.
16. The last dose of strong CYP3A inhibitor or CYP3A inducer (including food, western
medicine, traditional Chinese medicine) is less than 5 half-lives before the first
dose of study drug, or plans to take concomitant drugs or foods with strong CYP3A
inhibition or induction during the study.
17. Known allergy to any excipients of the study drug.
18. Subjects with conditions that in the investigator's opinion are not suitable for
participating in this trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital
Address:
City:
Hefei
Zip:
230036
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lianxin Liu
Email:
liulx@ustc.edu.cn
Facility:
Name:
Cancer Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiao Li
Email:
simonlixiao@263.net
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Haitao Zhao
Email:
zhaoht@pumch.cn
Facility:
Name:
Beijing Youan Hosptital,Capital Medical University
Address:
City:
Beijing
Zip:
100069
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chunwang Yuan
Email:
18612778605@163.com
Contact backup:
Last name:
Hongyong Zhang
Email:
13810108505@163.com
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xu Zhu
Email:
drzhuxu@163.com
Facility:
Name:
Beijing Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Yunbo Zhao
Email:
zhaoyb1206@163.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fujian
Zip:
350011
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hailan Lin
Email:
fjzljr@qq.com
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yanling Chen
Email:
drchenyl@126.com
Facility:
Name:
Mengchao hepatobiliary Hospital of FuJian Medical university
Address:
City:
FuZhou
Zip:
350025
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Kecan Lin
Email:
kclin2002@126.com
Facility:
Name:
Foshan First People's Hospital
Address:
City:
Foshan
Zip:
528000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jing Wu
Email:
13877296262@163.com
Facility:
Name:
Sun Yat-sen Memorial Hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chao Liu
Email:
liuchao3@mail.sysu.edu.cn
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ruihua Xu
Email:
xurh@sysucc.org.cn
Facility:
Name:
ZhuJiang Hospital of Southern Medical University
Address:
City:
Guangzhou
Zip:
510280
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiming Ding
Email:
DWM-2001@163.com
Facility:
Name:
Hebei Medical University Fourth Hospital
Address:
City:
Shijiazhuang
Zip:
050011
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fei Yin
Email:
Yinfei_4y@sina.com
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150081
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhiwei Li
Email:
lzhw0451@163.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xinfang Hou
Email:
houxinfang2013@163.com
Facility:
Name:
First Affiliated Hospital of Zhengzhou University.
Address:
City:
Zhengzhou
Zip:
450066
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qingxia Fan
Email:
fqx2243@126.com
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430062
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fuxiang Zhou
Email:
happyzhoufx@sina.com
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhang Feng
Email:
zhangfeng_329@126.com
Facility:
Name:
Human Provincial People's Hospital
Address:
City:
Changsha
Zip:
410002
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chuang Peng
Email:
1518364280@qq.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Contact:
Last name:
Shanzhi Gu
Email:
105575191@qq.com
Facility:
Name:
The Third Xiangya Hospital of Central South Uninversity
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Feizhou Huang
Email:
Huangfeizhou1009@163.com
Facility:
Name:
Changzhou Tumor Hospital
Address:
City:
Changzhou
Zip:
213000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Bi Yanzhi
Email:
623447244@qq.com
Facility:
Name:
Jiangyin Renmin Hospital
Address:
City:
Jiangyin
Zip:
214499
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lichun Deng
Email:
18921233265@163.com
Facility:
Name:
The Affiliated Hospital of Nanjing University Meidical School
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Shen Jie
Email:
shenjie2008nju@163.com
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhixiang Zhuang
Email:
13951106391@139.com
Facility:
Name:
Xuzhou Central Hospital
Address:
City:
Xuzhou
Zip:
221009
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jinsong Li
Email:
18952171970@189.cn
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jianbing Wu
Email:
hhgwjb@163.com
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Chaoliu Dai
Email:
278170678@qq.com
Facility:
Name:
Liaoning Cancer Hospital&Institute
Address:
City:
Shenyang
Zip:
110042
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jingdong Zhang
Email:
13804027878@163.com
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Qiang Tu
Email:
52689703@qq.com
Facility:
Name:
General Hospital of Ningxia Medical University
Address:
City:
Yinchuan
Zip:
750004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ping Chen
Email:
Chenping2536@qq.com
Facility:
Name:
Tangdu Hospital of the Fourth Military Medical University
Address:
City:
Xi'an
Zip:
710038
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jikai Yin
Email:
yjkfmmuu@hotmail.com
Facility:
Name:
Qilu Hospital
Address:
City:
Jinan
Zip:
250012
Country:
China
Status:
Recruiting
Contact:
Last name:
Yufeng Cheng
Email:
qlcyf@163.com
Facility:
Name:
Jinan Central Hospital
Address:
City:
Jinan
Zip:
250013
Country:
China
Status:
Recruiting
Contact:
Last name:
MeiLi Sun
Email:
s18953116532@163.com
Facility:
Name:
Affiliated Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
ZuoXing Niu
Email:
nzxsdth@163.com
Contact backup:
Last name:
Tian He
Email:
tianhejn@sina.com
Facility:
Name:
ZhongShan Hospital
Address:
City:
Shanghai
Zip:
200123
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhou Jian
Email:
zhou.jian@zs-hospital.sh.cn
Facility:
Name:
The Third Affiliated Hospital of Naval Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Kui Wang
Email:
wangkuiykl@163.com
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xielin Feng
Email:
llxxff17@163.com
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lunan Yan
Email:
yanlunan688@163.com
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wei Lu
Email:
luwei1966@126.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jieer Ying
Email:
jieerying01@163.com
Facility:
Name:
Shulan（Hangzhou） Hospital
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wu zhang
Email:
Wu.zhang@shulan.com
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Tingbo Liang
Email:
liangtingbo@zju.edu.cn
Start date:
November 15, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
Beijing InnoCare Pharma Tech Co., Ltd.
Agency class:
Industry
Source:
Beijing InnoCare Pharma Tech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05678270
