NCT05441475

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

A Phase 2, Open-Label Study of ABSK-011 Plus Atezolizumab or Standard of Care to Assess Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy in Patients With Advanced or Unresectable Hepatocellular Carcinoma

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Abbisko Therapeutics Co, Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

During part a, all subjects will receive continuous oral administration of absk-011 once a day (QD) or twice a day (bid) with an initial dose of 180 mg, and intravenous infusion (IV) of 1200 mg of atilizumab every 21 days (q3w). After the first subject (sentinel subject) in each dose cohort completed the first combined medication, follow-up subjects were administered at least 7 days later. Part B will include subjects with advanced unresectable HCC who have not previously received systemic therapy or only received first-line systemic therapy and whose Fgf19 expression is positive. No more than 70% of the enrolled subjects have only received first-line systemic therapy Part C1 is intended to enroll 6 subjects with advanced hepatocellular carcinoma (HCC) to receive ABSK-011 in combination with atezolizumab and bevacizumab.ABSK-011 will be administered orally at 200 mg twice daily (BID), with a single dose administered on Cycle 1 Day 1 (C1D1). The study drug should be taken with food, preferably within 30 minutes after a meal. Atezolizumab and bevacizumab will be administered in accordance with a every-3-week (Q3W) schedule.Safety and tolerability assessments will be conducted based on dose-limiting toxicities (DLTs) observed during Cycle 1 (21 days). Part C2 is planned to enroll a maximum of 48 subjects with advanced HCC, divided into two stages: Stage 1 of Part C2 intends to enroll 12 subjects with FGF19-overexpressing advanced HCC, who will be randomized 1:1 to two parallel treatment arms: Arm 1: ABSK-011 plus toripalimab plus bevacizumab biosimilar Arm 2: toripalimab plus bevacizumab biosimilar ABSK-011 will be administered orally at 200 mg BID, with a single dose administered on C1D1, and taken with food, preferably within 30 minutes after a meal. All intravenous agents will be administered on a Q3W schedule.Safety and tolerability evaluations will be performed for each treatment arm based on DLTs observed during Cycle 1 (21 days). Stage 2 of Part C2 is planned to enroll up to 36 subjects with FGF19-overexpressing advanced HCC, randomized 1:1 to Arm 1 or Arm 2, to further characterize the efficacy and safety profile of ABSK-011 in combination with standard of care (SOC).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w	During part a, all subjects will receive continuous oral administration of absk-011 once a day (QD) or twice a day (bid) with an initial dose of 180 mg, and intravenous infusion (IV) of 1200 mg of atilizumab every 21 days (q3w). After the first subject (sentinel subject) in each dose cohort completed the first combined medication, follow-up subjects were administered at least 7 days later
DRUG	ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kg	Part C1 is intended to enroll 6 subjects with advanced hepatocellular carcinoma (HCC) to receive ABSK-011 in combination with atezolizumab and bevacizumab.ABSK-011 will be administered orally at 200 mg twice daily (BID), with a single dose administered on Cycle 1 Day 1 (C1D1).
DRUG	ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kg	Part C2 is planned to enroll a maximum of 48 subjects with advanced HCC, divided into two stages: tage 1 of Part C2 intends to enroll 12 subjects with FGF19-overexpressing advanced HCC, who will be randomized 1:1 to two parallel treatment arms: Arm 1: ABSK-011 plus toripalimab plus bevacizumab biosimilar Arm 2: toripalimab plus bevacizumab biosimilar ABSK-011 will be administered orally at 200 mg BID, with a single dose administered on C1D1, and taken with food, preferably within 30 minutes after a meal. All intravenous agents will be administered on a Q3W schedule.Safety and tolerability evaluations will be performed for each treatment arm based on DLTs observed during Cycle 1 (21 days). Stage 2 of Part C2 is planned to enroll up to 36 subjects with FGF19-overexpressing advanced HCC, randomized 1:1 to Arm 1 or Arm 2, to further characterize the efficacy and safety profile of ABSK-011 in combination with standard of care (SOC).

Timeline

• Start date: 2021-12-30
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2022-07-01
• Last updated: 2026-02-25

Locations

1 site across 1 country: China