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

NCT ID: NCT05441475

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-30
• Study Completion Date: 2024-10-10

Brief 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.

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w

Intervention Type: DRUG

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).

Interventions

ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. before implementing any program related procedures, the subjects should understand and voluntarily sign the written informed consent and indicate the date. Subjects should be able and willing to follow the study follow-up and study procedures in the protocol.

2. there is no limit on gender, and the age when signing the informed consent is ≥ 18 years old.

3. part a: subjects with advanced or unresectable HCC who must be confirmed by histology, cytology or imaging, are not suitable for curative surgery and / or local treatment, have disease progression or cannot tolerate standard treatment after standard treatment, and have no standard treatment due to physical conditions or disease status (according to local / regional guidelines), and the child Pugh score is 5-6.

Part b: subjects with advanced or unresectable HCC who must be confirmed histologically or cytologically, are not suitable for curative surgery and / or local regional treatment, and have not previously received systematic treatment or only received first-line systematic treatment-

Exclusion Criteria

1. history of autoimmune diseases

2. have a history of the second primary malignant tumor other than HCC within 5 years before screening,

3. have a history of uncorrectable electrolyte disorders that affect serum potassium, calcium or phosphorus levels.

4. meningeal metastasis or central nervous system (CNS) metastasis -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbisko Therapeutics Co, Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Hubei, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuan LU

Role: CONTACT

clinical@abbisko.cn

+86 021-68910052

Facility Contacts

Chang Shu, Secretary

Role: primary

tongjigcp@163.com

+86027-83663940

Other Identifiers

ABSK-011-201

Identifier Type: -

Identifier Source: org_study_id