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Trial record 1 of 3 for:    ABSK011
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A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab in HCC Patients

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ClinicalTrials.gov Identifier: NCT05441475
Recruitment Status : Recruiting
First Posted : July 1, 2022
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
Abbisko Therapeutics Co, Ltd

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w Phase 2

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Absk-011 combined with atelizumab in the treatment of patients with advanced or unresectable HCC
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 30, 2021
Estimated Primary Completion Date : July 20, 2024
Estimated Study Completion Date : October 10, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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-011 180 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).


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the safety and tolerability of ABSK-011 combined with atezolizumab mab in subjects with advanced or unresectable HCC [ Time Frame: 10 month ]
    Incidence of dose limiting toxicity (DLT) in the first cycle；Incidence and grade of AE, SAE and AESI by CTCAE v5.0

  2. To evaluate the objective response rate of ABSK-011 combined with atezolizumab in subjects with advanced FGF19 overexpression or unresectable HCC [ Time Frame: 10month ]
    Objective response rate (ORR): complete response and partial response determined by the investigator according to RECIST v1.1 and to be confirmed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05441475


Contacts
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Contact: Yuan LU +86 021-68910052 clinical@abbisko.cn

Locations
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China, Shanghai
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology Recruiting
Hubei, Shanghai, China, 430030
Contact: Chang Shu, Secretary    +86027-83663940    tongjigcp@163.com   
Principal Investigator: Xiaoping Chen         
Sponsors and Collaborators
Abbisko Therapeutics Co, Ltd
More Information
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Responsible Party: Abbisko Therapeutics Co, Ltd
ClinicalTrials.gov Identifier: NCT05441475    
Other Study ID Numbers: ABSK-011-201
First Posted: July 1, 2022    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases