A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (ICC)
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma (ICC)
Eligibility Criteria
Inclusion Criteria: 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 systemic 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. Exclusion Criteria: 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. 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.
Sites / Locations
- Anhui Provincial Hospital
- Cancer Hospital, Chinese Academy of Medical Sciences
- Peking Union Medical College Hospital
- Beijing Youan Hosptital,Capital Medical University
- Beijing Cancer Hospital
- Beijing HospitalRecruiting
- Fujian Cancer Hospital
- Fujian Medical University Union Hospital
- Mengchao hepatobiliary Hospital of FuJian Medical university
- Foshan First People's Hospital
- Sun Yat-sen Memorial Hospital
- Sun Yat-sen University Cancer Center
- ZhuJiang Hospital of Southern Medical UniversityRecruiting
- Hebei Medical University Fourth Hospital
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- First Affiliated Hospital of Zhengzhou University.
- Zhongnan Hospital of Wuhan University
- Hubei Cancer Hospital
- Human Provincial People's Hospital
- Hunan Cancer HospitalRecruiting
- The Third Xiangya Hospital of Central South Uninversity
- Changzhou Tumor Hospital
- Jiangyin Renmin Hospital
- The Affiliated Hospital of Nanjing University Meidical School
- The Second Affiliated Hospital of Soochow University
- Xuzhou Central Hospital
- The Second Affiliated Hospital of Nanchang University
- Shengjing Hospital of China Medical University
- Liaoning Cancer Hospital&Institute
- Jiangxi Cancer Hospital
- General Hospital of Ningxia Medical University
- Tangdu Hospital of the Fourth Military Medical University
- Qilu HospitalRecruiting
- Jinan Central HospitalRecruiting
- Affiliated Cancer Hospital of Shandong First Medical University
- ZhongShan Hospital
- The Third Affiliated Hospital of Naval Medical University
- Sichuan Cancer Hospital
- West China Hospital of Sichuan University
- Tianjin Cancer Hospital
- Zhejiang Cancer Hospital
- Shulan(Hangzhou) Hospital
- The First Affiliated Hospital of Zhejiang University School of Medicine
Arms of the Study
Arm 1
Experimental
ICP-192