169
Participants
Start Date
June 26, 2023
Primary Completion Date
March 15, 2026
Study Completion Date
June 30, 2026
ABSK121-NX
In the escalation part, patients will receive a single dose of oral ABSK121-NX on Day -7 followed by a 7-day washout (Day -7 dosing day as 1st day of wash out) as a run-in period to access the safety and PK of ABSK121-NX. Then, patients will continuously receive ABSK121-NX once daily (QD) starting at C1D1 and continuing in subsequent cycles (28-day cycles). The starting dose is 3mg QD. In the expansion part, patients will each receive oral ABSK121-NX at the RDE in repeated 28-day cycles.
Gabrail Cancer Center Research, Canton
Karmanos Cancer Institute, Detroit
Comprehensive Cancer Centers of Nevada, Las Vegas
UC San Diego Moores Cancer Center, La Jolla
Chongqing University Cancer Hospital, Chongqing
The First Affiliated Hospital of Henan University of Science & Technology, Luoyang
The First Affiliated Hospital of Zhengzhou University, Zhengzhou
Hubei Cancer Hospital, Wuhan
Hunan Central Hospital, Changsha
The Affiliated Hospital of Inner Mongolia Medical University, Hohhot
The First Affiliated Hospital of Nanchang University, Nanchang
Jilin Cancer Hospital, Changchun
The First Hospital of China Medical University, Shenyang
Shanghai East Hospital Tongji University, Shanghai
Shanxi Provincial Cancer Hospital, Taiyuan
West China School of Medicine/West China Hospital of Sichuan University, Chengdu
Mianyang Central Hospital, Mianyang
Zhejiang University Cancer Hospital, Hangzhou
Fujian Cancer Hospital (Department of Hepatobiliary and Pancreatic Oncology /Phase I Ward), Fuzhou
Harbin Medical University Cancer Hospital (Gastroenterology Department 2nd Ward), Haerbin
Zhongshan Hospital of Fudan University (Hepatological Surgery Department), Shanghai
Zhongshan Hospital of Fudan University (Medical Oncology Department), Shanghai
Liaoning Cancer Hospital (Phase I Ward), Shenyang
Yantai Yuhuangding Hospital (Department of Medical Oncology, 1), Yantai
Lead Sponsor
Abbisko Therapeutics Co, Ltd
INDUSTRY