Intrahepatic Cholangiocarcinoma (ICC)Phase 2NCT05678270
A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
A Phase 2 study testing ICP-192 in people with Intrahepatic Cholangiocarcinoma (ICC), run by Beijing InnoCare Pharma Tech Co., Ltd. at 44 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma (ICC)
- What is being tested?
- ICP-192
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 44 sitesChina
- Study dates
- 15 Nov 2022to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the ICF and Age ≥ 18 years old, either sex.
- ECOG score of 0-1.
- Life expectancy > 3 months.
- 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.
- FGFR2 fusion /rearrangement as confirmed by the central laboratory.
- At least one measurable lesion at screening as target lesion per RECIST 1.1.
- Organ functions meeting the protocol requirements.
- Contraception according to the protocol requirements.
Who cannot join
- Presence of other malignancies requiring medical intervention.
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- 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.
- Known symptomatic central nervous system (CNS) metastases.
- 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.
- Currently uncontrolled cardiovascular and cerebrovascular diseases, or a past medical history.
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- 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%).
- Current active bleeding, such as deep venous thrombosis, portal hypertension signs leading to gastroesophageal venous bleeding.
- Wound with active infection.
- 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.
- Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity
- 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.
- 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.
- Active HBV infection, Active HCV infection, HIV infection.
- 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.
- 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.
- Known allergy to any excipients of the study drug.
- Subjects with conditions that in the investigator's opinion are not suitable for participating in this trial.
Trial locations and contacts
44 sites in 1 country. Contact the study team or a site near you to ask about taking part.
44 sites in 1 country
China44 sites, 44 recruiting
- Not yet recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Xiao Li, simonlixiao@263.net
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Haitao Zhao, zhaoht@pumch.cn
- Not yet recruiting
Beijing Youan Hosptital,Capital Medical University
Beijing, Beijing Municipality, 100069
Chunwang Yuan, 18612778605@163.com
Hongyong Zhang, 13810108505@163.com
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Xu Zhu, drzhuxu@163.com
- Recruiting
Beijing Hospital
Beijing, Beijing Municipality, 100730
Yunbo Zhao, zhaoyb1206@163.com
- Not yet recruiting
Human Provincial People's Hospital
Changsha, Hunan, 410002
Chuang Peng, 1518364280@qq.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410013
Shanzhi Gu, 105575191@qq.com
- Not yet recruiting
The Third Xiangya Hospital of Central South Uninversity
Changsha, Hunan, 410013
Feizhou Huang, Huangfeizhou1009@163.com
- Not yet recruiting
Changzhou Tumor Hospital
Changzhou, Jiangsu, 213000
Bi Yanzhi, 623447244@qq.com
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Xielin Feng, llxxff17@163.com
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Lunan Yan, yanlunan688@163.com
- Not yet recruiting
Foshan First People's Hospital
Foshan, Guangdong, 528000
Jing Wu, 13877296262@163.com
- Not yet recruiting
Fujian Cancer Hospital
Fujian, Fujian, 350011
Hailan Lin, fjzljr@qq.com
- Not yet recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Yanling Chen, drchenyl@126.com
- Not yet recruiting
Mengchao hepatobiliary Hospital of FuJian Medical university
Fuzhou, Fujian, 350025
Kecan Lin, kclin2002@126.com
- Not yet recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Chao Liu, liuchao3@mail.sysu.edu.cn
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua Xu, xurh@sysucc.org.cn
- Recruiting
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Weiming Ding, DWM-2001@163.com
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Jieer Ying, jieerying01@163.com
- Not yet recruiting
Shulan（Hangzhou） Hospital
Hangzhou, Zhejiang, 310009
Wu zhang, Wu.zhang@shulan.com
- Not yet recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Tingbo Liang, liangtingbo@zju.edu.cn
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Zhiwei Li, lzhw0451@163.com
- Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230036
Lianxin Liu, liulx@ustc.edu.cn
- Not yet recruiting
Jiangyin Renmin Hospital
Jiangyin, Jiangsu, 214499
Lichun Deng, 18921233265@163.com
- Recruiting
Qilu Hospital
Jinan, Shandong, 250012
Yufeng Cheng, qlcyf@163.com
- Recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
MeiLi Sun, s18953116532@163.com
- Not yet recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
ZuoXing Niu, nzxsdth@163.com
Tian He, tianhejn@sina.com
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Jianbing Wu, hhgwjb@163.com
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Nanchang, 330029
Qiang Tu, 52689703@qq.com
- Not yet recruiting
The Affiliated Hospital of Nanjing University Meidical School
Nanjing, Jiangsu, 210000
Shen Jie, shenjie2008nju@163.com
- Not yet recruiting
ZhongShan Hospital
Shanghai, Shanghai Municipality, 200123
Zhou Jian, zhou.jian@zs-hospital.sh.cn
- Not yet recruiting
The Third Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200433
Kui Wang, wangkuiykl@163.com
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
Chaoliu Dai, 278170678@qq.com
- Not yet recruiting
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, 110042
Jingdong Zhang, 13804027878@163.com
- Not yet recruiting
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050011
Fei Yin, Yinfei_4y@sina.com
- Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Zhixiang Zhuang, 13951106391@139.com
- Not yet recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Wei Lu, luwei1966@126.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430062
Fuxiang Zhou, happyzhoufx@sina.com
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Zhang Feng, zhangfeng_329@126.com
- Not yet recruiting
Tangdu Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, 710038
Jikai Yin, yjkfmmuu@hotmail.com
- Not yet recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Jinsong Li, 18952171970@189.cn
- Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Ping Chen, Chenping2536@qq.com
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Xinfang Hou, houxinfang2013@163.com
- Not yet recruiting
First Affiliated Hospital of Zhengzhou University.
Zhengzhou, Henan, 450066
Qingxia Fan, fqx2243@126.com
About this study
Official title: A Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of ICP-192 in Subjects With Unresectable or Metastatic Intrahepatic Cholangiocarcinoma With FGFR2 Fusions/Rearrangements Who Have Failed Prior Therapy
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
- Intrahepatic Cholangiocarcinoma (ICC)
- Being tested
- ICP-192
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-192Drug
ICP-192 is a round, uncoated tablet, 5mg, orally.
| Study group | Role | What they receive |
|---|---|---|
| ICP-192 | Experimental | Not described Receives: Drug: ICP-192 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: Up to 3 years
Secondary outcomes (12)
Progression-free survival (PFS)
Measured: Up to 3 years
Disease control rate (DCR)
Measured: Up to 3 years
Duration of response (DOR)
Measured: Up to 3 years
Time to response (TTR)
Measured: Up to 3 years
Overall survival (OS)
Measured: Up to 3 years
The adverse event (AE) of ICP-192 assessed by NCI-CTCAE V5.0
Measured: Up to 3 years
Maximum concentration (Cmax)
Measured: Up to 3 years
Time to maximum concentration (Tmax)
Measured: Up to 3 years
Half-life (T1/2)
Measured: Up to 3 years
Area under the concentration-time curve (AUC)
Measured: Up to 3 years
Apparent clearance (CL/F)
Measured: Up to 3 years
Terminal apparent volume of distribution (Vz/F)
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start15 Nov 2022
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholangiocarcinoma (ICC)Studies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Li, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678270
- Sponsor's protocol ID
- ICP-CL-00305
- Status last verified
- Feb 2024
- First submitted
- 23 Dec 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of ICP-192 in Subjects With Unresectable or Metastatic Intrahepatic Cholangiocarcinoma With FGFR2 Fusions/Rearrangements Who Have Failed Prior Therapy
- ClinicalTrials.gov ID
- NCT05678270
- Acronym / sponsor ID
- ICP-CL-00305
- Conditions
- Intrahepatic Cholangiocarcinoma (ICC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICP-192 | Experimental | Drug: ICP-192 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed the ICF and Age ≥ 18 years old, either sex.
- ECOG score of 0-1.
- Life expectancy > 3 months.
- 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.
- FGFR2 fusion /rearrangement as confirmed by the central laboratory.
Key exclusion criteria (18 listed)
- Presence of other malignancies requiring medical intervention.
- Prior treatment with selective FGFR inhibitors or FGFR antibodies.
- 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.
- Known symptomatic central nervous system (CNS) metastases.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICP-192ICP-192 is a round, uncoated tablet, 5mg, orally. | Drug | ICP-192 |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 3 years
12 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 3 years
Disease control rate (DCR)
Time frame: Up to 3 years
Duration of response (DOR)
Time frame: Up to 3 years
Time to response (TTR)
Time frame: Up to 3 years
Overall survival (OS)
Time frame: Up to 3 years
The adverse event (AE) of ICP-192 assessed by NCI-CTCAE V5.0
Time frame: Up to 3 years
Maximum concentration (Cmax)
Time frame: Up to 3 years
Time to maximum concentration (Tmax)
Time frame: Up to 3 years
Half-life (T1/2)
Time frame: Up to 3 years
Area under the concentration-time curve (AUC)
Time frame: Up to 3 years
Apparent clearance (CL/F)
Time frame: Up to 3 years
Terminal apparent volume of distribution (Vz/F)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jin Li principal investigator
Shanghai East Hospital
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICP-192 in people with Intrahepatic Cholangiocarcinoma (ICC), run by Beijing InnoCare Pharma Tech Co., Ltd. at 44 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin Li (021-38804518, lijin@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.