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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05441475
• Other study ID #: ABSK-011-201
• Status: Recruiting
• Phase: Phase 2
• Start date: December 30, 2021
• Est. completion date: October 10, 2024

Study information

• Verified date: September 2022
• Source: Abbisko Therapeutics Co, Ltd
• Contact: Yuan LU
• Phone: +86 021-68910052
• Email: clinical[@]abbisko.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: October 10, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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).

Locations

Country	Name	City	State
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Hubei	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Abbisko Therapeutics Co, Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	10 month
Primary	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	10month