FGF19 Overexpression Combination Unified Study in HCC-19

NCT06978933 | Recruiting Phase 2

• 1 other identifier: ABSK-011-2002-IIT
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HCC - Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• To evaluate the objective response rate of ABSK-011 plus ABSK043 in patients with previously treated unresectable or metastatic HCC harboring FGF19 overexpression

  Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed

  10 months

Study Arms (1)

ABSK-011+ABSK043

EXPERIMENTAL

Drug: ABSK-011

Interventions

ABSK-011 DRUG

Drug: ABSK-011 RP2D according to the results of Phase I trial Other Names: • FGFR4 inhibitor Drug: ABSK043 RP2D according to the results of Phase I trial Other Names: • Oral PD-L1 inhibitor

ABSK-011+ABSK043

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with HCC confirmed by pathological histology or cytology, or meeting the clinical diagnostic criteria for HCC as the AASLD or Guidelines for the diagnosis and treatment of primary liver cancer (China).
• Progression of disease confirmed by imaging after receiving at least one line of systemic therapy
• The central laboratory test report for FGF19 overexpression positive.
• ECOG performance status of 0 or 1;
• Adequate organ and marrow function defined by study-specified laboratory tests;

You may not qualify if:

• Has received prior therapy with FGFR4 or pan-FGFR inhibitors;
• Hypersensitivity for any constituent of ABSK-011 or ABSK043;
• Past or current hepatic encephalopathy; patients with known untreated or inadequately controlled central nervous system metastases that have not been effectively managed with treatment
• have other malignant tumors that are currently in a progressive stage or require effective treatment
• Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Qiang Xia, MD

  Shanghai Jiao Tong University school of medicine affiliate Renji Hospital

  STUDY CHAIR

• Hao Feng, Ph.D.,MD

  Shanghai Jiao Tong University school of medicine affiliate Renji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Feng, Ph.D.,MD

CONTACT

+8615000901110; surgeonfeng@live.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)