RecruitingPhase 1NCT04906434

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

A Phase 1, Open-Label Study of ABSK-011 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors

Sponsor

Abbisko Therapeutics Co, Ltd

Enrollment

200 participants

Start Date

Feb 26, 2020

Study Type

INTERVENTIONAL

Conditions

Advanced Liver Cancer

Summary

This is an open-label phase 1 study with an escalation part and an expansion part.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called ABSK-011 in people with advanced solid tumors, with a particular focus on liver cancer (HCC) that has a specific molecular marker called FGF19 overexpression. The first phase tests safety and dosing; the second phase tests effectiveness in liver cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have an advanced solid tumor that has progressed on or is intolerant to standard therapy - For liver cancer (HCC): your tumor is at intermediate or advanced stage (BCLC B or C), your liver function is reasonably preserved (Child-Pugh 5-7), and your tumor tests positive for FGF19 overexpression - You have at least one measurable tumor **You may NOT be eligible if...** - Your liver cancer has signs of liver failure (encephalopathy, significant ascites) - Your organ function (blood counts, liver, kidney) does not meet requirements - You are pregnant or breastfeeding - You have had certain prior cancer treatments that are disqualifying Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABSK-011

During the escalation part, the administration of oral ABSK-011 will be guided by "3+3"design 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.

Locations(32)

Mayo Clinic

Phoenix, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

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

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Sun Yat Sen Memorial Hospital

Guangzhou, Guangdong, China

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, China

Weifang People's Hospital

Weifang, Hebei, China

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

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

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Suzhou University Affiliated Second Hospital

Suzhou, Jiangsu, China

Tonghua Central Hospital

Tonghua, Jilin, China

Shengjing Hospital of China medical university

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Jinan Central Hospital

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Ningbo Huamei Hospital, University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

National Cheng Kung University Hospitals

Tainan, Taiwan

Nation Taiwan University Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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