Actively Recruiting
A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2024-02-07
70
Participants Needed
44
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed the informed consent form and are 18 years of age or older, any sex
- Have an ECOG performance status score of 0 or 1
- Have a life expectancy of more than 3 months
- Have histopathologically or cytopathologically confirmed intrahepatic cholangiocarcinoma with unresectable, recurrent or metastatic tumor (stage IV) that progressed after at least one line of chemotherapy
- Have FGFR2 fusion or rearrangement confirmed by a central laboratory
- Have at least one measurable lesion at screening per RECIST 1.1 criteria
- Meet organ function requirements specified in the protocol
- Agree to use contraception according to protocol requirements
You will not qualify if you...
- Have other malignancies requiring medical intervention
- Have received prior treatment with selective FGFR inhibitors or FGFR antibodies
- Have had biological products, radical radiotherapy, or other investigational drugs within 4 weeks before the first dose of study drug
- Have had chemotherapy within 3 weeks before the first dose of study drug
- Have known symptomatic central nervous system metastases
- Have not recovered from toxicity caused by previous anti-tumor treatment and have grade 2 or higher adverse events at first dose
- Have uncontrolled cardiovascular or cerebrovascular diseases or relevant past medical history
- Have unstable or uncontrolled systemic disease such as active infection requiring intravenous therapy, uncontrolled hypertension, or diabetes mellitus with HbA1c over 8%
- Have active bleeding conditions such as deep venous thrombosis or gastroesophageal venous bleeding
- Have wounds with active infection
- Have had major surgery within 4 weeks or minor surgery within 2 weeks before first dose
- Have corneal or retinal abnormalities that increase risk of ocular toxicity
- Have extensive tissue calcification except certain mild or asymptomatic cases
- Have serious gastrointestinal dysfunction affecting drug intake or swallowing
- Have active HBV, HCV, or HIV infection
- Are pregnant, breastfeeding, or planning pregnancy within 6 months after last dose (for females) or planning to father a child during study or within 6 months after last dose (for males)
- Have taken strong CYP3A inhibitors or inducers less than 5 half-lives before first dose or plan to take them during study
- Are allergic to any excipients of the study drug
- Are judged by investigator as unsuitable for participation in the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 44 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230036
Not Yet Recruiting
2
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
Not Yet Recruiting
4
Beijing Youan Hosptital,Capital Medical University
Beijing, Beijing Municipality, China, 100069
Not Yet Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
6
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
7
Fujian Cancer Hospital
Fujian, Fujian, China, 350011
Not Yet Recruiting
8
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Not Yet Recruiting
9
Mengchao hepatobiliary Hospital of FuJian Medical university
Fuzhou, Fujian, China, 350025
Not Yet Recruiting
10
Foshan First People's Hospital
Foshan, Guangdong, China, 528000
Not Yet Recruiting
11
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
12
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
13
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
14
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China, 050011
Not Yet Recruiting
15
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
16
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
17
First Affiliated Hospital of Zhengzhou University.
Zhengzhou, Henan, China, 450066
Not Yet Recruiting
18
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430062
Not Yet Recruiting
19
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Not Yet Recruiting
20
Human Provincial People's Hospital
Changsha, Hunan, China, 410002
Not Yet Recruiting
21
Hunan Cancer Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
22
The Third Xiangya Hospital of Central South Uninversity
Changsha, Hunan, China, 410013
Not Yet Recruiting
23
Changzhou Tumor Hospital
Changzhou, Jiangsu, China, 213000
Not Yet Recruiting
24
Jiangyin Renmin Hospital
Jiangyin, Jiangsu, China, 214499
Not Yet Recruiting
25
The Affiliated Hospital of Nanjing University Meidical School
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
26
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
Not Yet Recruiting
27
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Not Yet Recruiting
28
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
29
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Not Yet Recruiting
30
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China, 110042
Not Yet Recruiting
31
Jiangxi Cancer Hospital
Nanchang, Nanchang, China, 330029
Not Yet Recruiting
32
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China, 750004
Not Yet Recruiting
33
Tangdu Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, China, 710038
Not Yet Recruiting
34
Qilu Hospital
Jinan, Shandong, China, 250012
Actively Recruiting
35
Jinan Central Hospital
Jinan, Shandong, China, 250013
Actively Recruiting
36
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Not Yet Recruiting
37
ZhongShan Hospital
Shanghai, Shanghai Municipality, China, 200123
Not Yet Recruiting
38
The Third Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China, 200433
Not Yet Recruiting
39
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
40
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
41
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
42
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Not Yet Recruiting
43
Shulan（Hangzhou） Hospital
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
44
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
Research Team
J
Jin Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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