Status:
UNKNOWN
A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab in HCC Patients
Lead Sponsor:
Abbisko Therapeutics Co, Ltd
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 u...
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 ati...
Eligibility Criteria
Inclusion
- 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.
- there is no limit on gender, and the age when signing the informed consent is ≥ 18 years old.
- 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
- history of autoimmune diseases
- have a history of the second primary malignant tumor other than HCC within 5 years before screening,
- have a history of uncorrectable electrolyte disorders that affect serum potassium, calcium or phosphorus levels.
- meningeal metastasis or central nervous system (CNS) metastasis -
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05441475
Start Date
December 30 2021
End Date
October 10 2024
Last Update
September 26 2022
Active Locations (1)
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1
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Hubei, Shanghai Municipality, China, 430030