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

Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Beijing Hospital
RECRUITING
Beijing
Beijing Youan Hosptital,Capital Medical University
NOT_YET_RECRUITING
Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Human Provincial People's Hospital
NOT_YET_RECRUITING
Changsha
Hunan Cancer Hospital
RECRUITING
Changsha
The Third Xiangya Hospital of Central South Uninversity
NOT_YET_RECRUITING
Changsha
Changzhou Tumor Hospital
NOT_YET_RECRUITING
Changzhou
Sichuan Cancer Hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Foshan First People's Hospital
NOT_YET_RECRUITING
Foshan
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fujian
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Mengchao hepatobiliary Hospital of FuJian Medical university
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen Memorial Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
ZhuJiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Shulan(Hangzhou) Hospital
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Anhui Provincial Hospital
NOT_YET_RECRUITING
Hefei
Jiangyin Renmin Hospital
NOT_YET_RECRUITING
Jiangyin
Affiliated Cancer Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
Jinan Central Hospital
RECRUITING
Jinan
Qilu Hospital
RECRUITING
Jinan
Jiangxi Cancer Hospital
NOT_YET_RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
The Affiliated Hospital of Nanjing University Meidical School
NOT_YET_RECRUITING
Nanjing
The Third Affiliated Hospital of Naval Medical University
NOT_YET_RECRUITING
Shanghai
ZhongShan Hospital
NOT_YET_RECRUITING
Shanghai
Liaoning Cancer Hospital&Institute
NOT_YET_RECRUITING
Shenyang
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Hebei Medical University Fourth Hospital
NOT_YET_RECRUITING
Shijiazhuang
The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Tianjin Cancer Hospital
NOT_YET_RECRUITING
Tianjin
Hubei Cancer Hospital
NOT_YET_RECRUITING
Wuhan
Zhongnan Hospital of Wuhan University
NOT_YET_RECRUITING
Wuhan
Tangdu Hospital of the Fourth Military Medical University
NOT_YET_RECRUITING
Xi'an
Xuzhou Central Hospital
NOT_YET_RECRUITING
Xuzhou
General Hospital of Ningxia Medical University
NOT_YET_RECRUITING
Yinchuan
First Affiliated Hospital of Zhengzhou University.
NOT_YET_RECRUITING
Zhengzhou
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Jin Li
lijin@csco.org.cn
021-38804518
Time Frame
Start Date: 2022-11-15
Estimated Completion Date: 2026-12
Participants
Target number of participants: 70
Treatments
Experimental: ICP-192
Related Therapeutic Areas
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.

This content was sourced from clinicaltrials.gov