A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab or SOC in HCC Patients

This study is an open phase II clinical study, which consists of part a and Part B. Part a will evaluate the safety and tolerability of absk-011 combined with atilizumab in patients with advanced or unresectable HCC to And pk/pd characteristics, and determine the treatment plan of Part B. Part B will evaluate absk-011 combined with atilizumab Anti FGF19 overexpression in advanced stage or non resectable patients who have not received systemic therapy or only received first-line systemic therapy before In addition to the safety and tolerability of HCC subjects, the antitumor activity of the combination will be further evaluated. Part C comprises two parts: Part C1 and Part C2. A maximum of 54 subjects with advanced or unresectable hepatocellular carcinoma (HCC) with FGF19 overexpression and no prior systemic therapy will be planned for enrollment. Eligible subjects will be prioritized for assignment to Part C2 to receive study treatment. Treatment will continue until the earliest occurrence of intolerable toxicity, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or study termination.

NCT Number	NCT05441475
Lead Sponsor	Abbisko Therapeutics Co, Ltd
Conditions	Hepatocellular Carcinoma
Enrollment	118 participants
Start Date	2021-12-30
Primary Completion	2028-12-31 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-25