A Study of ICP-192 in Patients With FGFR2-Rearranged Unresectable or Metastatic Intrahepatic Cholangiocarcinoma
- Registration Number
- NCT05678270
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICP-192 ICP-192 -
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Up to 3 years
- Secondary Outcome Measures
Name Time Method Duration of response (DOR) Up to 3 years Disease control rate (DCR) Up to 3 years Overall survival (OS) Up to 3 years Progression-free survival (PFS) Up to 3 years The adverse event (AE) of ICP-192 assessed by NCI-CTCAE V5.0 Up to 3 years Maximum concentration (Cmax) Up to 3 years Area under the concentration-time curve (AUC) Up to 3 years Terminal apparent volume of distribution (Vz/F) Up to 3 years Time to response (TTR) Up to 3 years Time to maximum concentration (Tmax) Up to 3 years Half-life (T1/2) Up to 3 years Apparent clearance (CL/F) Up to 3 years
Trial Locations
- Locations (44)
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Foshan First People's Hospital
🇨🇳Foshan, Guangdong, China
ZhuJiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Liaoning Cancer Hospital&Institute
🇨🇳Shenyang, Liaoning, China
Beijing Youan Hosptital,Capital Medical University
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Mengchao hepatobiliary Hospital of FuJian Medical university
🇨🇳FuZhou, Fujian, China
Hebei Medical University Fourth Hospital
🇨🇳Shijiazhuang, Hebei, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, 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
Human Provincial People's Hospital
🇨🇳Changsha, Hunan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, 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
Jiangxi Cancer Hospital
🇨🇳Nanchang, Nanchang, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Qilu Hospital
🇨🇳Jinan, Shandong, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Affiliated Cancer Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
The Third Affiliated Hospital of Naval Medical University
🇨🇳Shanghai, Shanghai, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
ZhongShan Hospital
🇨🇳Shanghai, Shanghai, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, 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
Tangdu Hospital of the Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, Guangdong, China
Fujian Cancer Hospital
🇨🇳Fujian, Fujian, China