A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
NCT ID: NCT05678270
Last Updated: 2024-02-07
Study Results
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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RECRUITING
PHASE2
70 participants
INTERVENTIONAL
2022-11-15
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ICP-192
ICP-192
ICP-192 is a round, uncoated tablet, 5mg, orally.
Interventions
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ICP-192
ICP-192 is a round, uncoated tablet, 5mg, orally.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jin Li
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Youan Hosptital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fujian, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Mengchao hepatobiliary Hospital of FuJian Medical university
Fuzhou, Fujian, China
Foshan First People's Hospital
Foshan, Guangdong, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
First Affiliated Hospital of Zhengzhou University.
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Human Provincial People's Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Third Xiangya Hospital of Central South Uninversity
Changsha, Hunan, China
Changzhou Tumor Hospital
Changzhou, Jiangsu, China
Jiangyin Renmin Hospital
Jiangyin, Jiangsu, China
The Affiliated Hospital of Nanjing University Meidical School
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital&Institute
Shenyang, Liaoning, China
Jiangxi Cancer Hospital
Nanchang, Nanchang, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Tangdu Hospital of the Fourth Military Medical University
Xi'an, Shaanxi, China
Qilu Hospital
Jinan, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
ZhongShan Hospital
Shanghai, Shanghai Municipality, China
The Third Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Shulan（Hangzhou） Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ICP-CL-00305
Identifier Type: -
Identifier Source: org_study_id
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