Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China
Location status: Recruiting
NCT Number: NCT06978933
This study is designed prospectively to investigate the safety and efficacy of ABSK-011 and ABSK043 in patients with previously treated unresectable or metastatic hepatocellular carcinoma (HCC) harboring FGF19 overexpression. ABSK-011, an oral, selective FGFR4 inhibitor which can irreversibly bind to the target. ABSK043, is an orally available, selective and potent inhibitor targeting the interaction of PD-1 and PD-L1, Safety, tolerability, and preliminary efficacy of ABSK-011 or ABSK043 were explored in a phase 1 trial ABSK-011-101 (NCT04906434) and ABSK043-101 (NCT04964375) trial, respectively. This trial focuses on the efficacy of the combination of ABSK-011 and ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Shanghai, China
Location status: Recruiting
The patients that meet the Inclusion and Exclusion Criteria will treat with ABSK-011 RP2D and ABSK043 RP2D until the disease progression
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drug: ABSK-011 RP2D according to the results of Phase I trial
Other Names:
Other Names:
Time frame: 10 months
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Contact information is provided by the study sponsor or research team.
RenJi Hospital
Other
A Prospective, Exploratory Study to Evaluate the Safety and Efficacy of the Combination of ABSK-011 and ABSK043 in Patients With Previously Treated Unresectable or Metastatic Hepatocellular Carcinoma With FGF19 Overexpression
Acronym: FOCUS-19
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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