Back to resultsA Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab in HCC Patients
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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 -
Sites / Locations
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w.
Arm 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
Outcomes
Primary Outcome Measures
To evaluate the safety and tolerability of ABSK-011 combined with atezolizumab mab in subjects with advanced or unresectable HCC
Incidence of dose limiting toxicity (DLT) in the first cycle；Incidence and grade of AE, SAE and AESI by CTCAE v5.0
To evaluate the objective response rate of ABSK-011 combined with atezolizumab in subjects with advanced FGF19 overexpression or unresectable HCC
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Secondary Outcome Measures
Full Information
NCT ID
NCT05441475
First Posted
June 28, 2022
Last Updated
September 22, 2022
Sponsor
Abbisko Therapeutics Co, Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05441475
Brief Title
A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab in HCC Patients
Official Title
A Phase 2, Open-Label Study of ABSK-011 Plus Atezolizumab to Assess Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy in Patients With Advanced or Unresectable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 30, 2021 (Actual)
Primary Completion Date
July 20, 2024 (Anticipated)
Study Completion Date
October 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbisko Therapeutics Co, Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Absk-011 combined with atelizumab in the treatment of patients with advanced or unresectable HCC
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w.
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w
Intervention Description
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).
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of ABSK-011 combined with atezolizumab mab in subjects with advanced or unresectable HCC
Description
Incidence of dose limiting toxicity (DLT) in the first cycle；Incidence and grade of AE, SAE and AESI by CTCAE v5.0
Time Frame
10 month
Title
To evaluate the objective response rate of ABSK-011 combined with atezolizumab in subjects with advanced FGF19 overexpression or unresectable HCC
Description
Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed
Time Frame
10month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan LU
Phone
+86 021-68910052
Email
clinical@abbisko.cn
Facility Information:
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
City
Hubei
State/Province
Shanghai
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Shu, Secretary
Phone
+86027-83663940
Email
tongjigcp@163.com
First Name & Middle Initial & Last Name & Degree
Xiaoping Chen
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab in HCC Patients
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