A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor

PHASE1RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

February 26, 2020

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Advanced Liver Cancer
Interventions
DRUG

ABSK-011

"During the escalation part, the administration of oral ABSK-011 will be guided by 3+3design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data. A separate food effect cohort may be conducted. In expansion part, patients will be treated at the selected RDE dose level."

Trial Locations (32)

10029

NOT_YET_RECRUITING

Icahn School of Medicine at Mount Sinai, New York

32224

NOT_YET_RECRUITING

Mayo Clinic, Jacksonville

33612

RECRUITING

Moffitt Cancer Center, Tampa

55905

NOT_YET_RECRUITING

Mayo Clinic, Rochester

77030

RECRUITING

MD Anderson Cancer Center, Houston

85054

NOT_YET_RECRUITING

Mayo Clinic, Phoenix

Unknown

COMPLETED

The First Affiliated Hospital of Bengbu Medical College, Bengbu

RECRUITING

Beijing Tsinghua Changgung Hospital, Beijing

WITHDRAWN

The Fifth Medical Center of the General Hospital of the Chinese People's Liberation Army, Beijing

RECRUITING

Chongqing Cancer Hospital, Chongqing

COMPLETED

Fujian Provincial Cancer Hospital, Fuzhou

COMPLETED

Sun Yat Sen Memorial Hospital, Guangzhou

COMPLETED

Guangxi Zhuang Autonomous Region People's Hospital, Nanning

COMPLETED

Weifang People's Hospital, Weifang

RECRUITING

Harbin Medical University Cancer Hospital, Haerbin

COMPLETED

First Affiliated Hospital of Henan University of Science and Technology, Luoyang

COMPLETED

Henan Cancer Hospital, Zhengzhou

COMPLETED

Hubei Cancer Hospital, Wuhan

RECRUITING

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan

COMPLETED

Hunan Cancer Hospital, Changsha

WITHDRAWN

Hunan Provincial People's Hospital, Changsha

COMPLETED

Suzhou University Affiliated Second Hospital, Suzhou

COMPLETED

Tonghua Central Hospital, Tonghua

COMPLETED

Shengjing Hospital of China medical university, Shenyang

COMPLETED

General Hospital of Ningxia Medical University, Yinchuan

COMPLETED

Jinan Central Hospital, Jinan

COMPLETED

Linyi Cancer Hospital, Linyi

WITHDRAWN

The First Affiliated Hospital of Xi'an Jiaotong University, Xian

RECRUITING

Mianyang Central Hospital, Mianyang

WITHDRAWN

Ningbo Huamei Hospital, University of Chinese Academy of Sciences, Ningbo

COMPLETED

National Cheng Kung University Hospitals, Tainan City

COMPLETED

Nation Taiwan University Hospital, Taipei

Sponsors
All Listed Sponsors
lead

Abbisko Therapeutics Co, Ltd

INDUSTRY

NCT04906434 - A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor | Biotech Hunter | Biotech Hunter