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

February 23, 2026 updated by: Abbisko Therapeutics Co, Ltd

A Phase 2, Open-Label Study of ABSK-011 Plus Atezolizumab or Standard of Care to Assess Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy in Patients With Advanced or Unresectable Hepatocellular Carcinoma

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.

Part C comprises two parts: Part C1 and Part C2. A maximum of 54 subjects with advanced or unresectable hepatocellular carcinoma (HCC) with FGF19 overexpression and no prior systemic therapy will be planned for enrollment. Eligible subjects will be prioritized for assignment to Part C2 to receive study treatment. Treatment will continue until the earliest occurrence of intolerable toxicity, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or study termination.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Part C1 is intended to enroll 6 subjects with advanced hepatocellular carcinoma (HCC) to receive ABSK-011 in combination with atezolizumab and bevacizumab.ABSK-011 will be administered orally at 200 mg twice daily (BID), with a single dose administered on Cycle 1 Day 1 (C1D1). The study drug should be taken with food, preferably within 30 minutes after a meal. Atezolizumab and bevacizumab will be administered in accordance with a every-3-week (Q3W) schedule.Safety and tolerability assessments will be conducted based on dose-limiting toxicities (DLTs) observed during Cycle 1 (21 days).

Part C2 is planned to enroll a maximum of 48 subjects with advanced HCC, divided into two stages:

Stage 1 of Part C2 intends to enroll 12 subjects with FGF19-overexpressing advanced HCC, who will be randomized 1:1 to two parallel treatment arms:

Arm 1: ABSK-011 plus toripalimab plus bevacizumab biosimilar Arm 2: toripalimab plus bevacizumab biosimilar ABSK-011 will be administered orally at 200 mg BID, with a single dose administered on C1D1, and taken with food, preferably within 30 minutes after a meal. All intravenous agents will be administered on a Q3W schedule.Safety and tolerability evaluations will be performed for each treatment arm based on DLTs observed during Cycle 1 (21 days).

Stage 2 of Part C2 is planned to enroll up to 36 subjects with FGF19-overexpressing advanced HCC, randomized 1:1 to Arm 1 or Arm 2, to further characterize the efficacy and safety profile of ABSK-011 in combination with standard of care (SOC).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Hubei, Shanghai Municipality, China, 430030
        • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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-

Part C: Subjects with histologically or cytologically confirmed advanced or unresectable HCC who are not eligible for curative surgery and/or locoregional therapy and have not received prior systemic therapy, and who meet the following criteria:

  1. Provide archived tumor tissue samples or undergo biopsy for FGF19 overexpression testing at the central laboratory.
  2. BCLC stage B or C, Child-Pugh score 5-6, no hepatic encephalopathy, and no ascites requiring medical intervention within 7 days prior to the first dose.
  3. At least 1 measurable target lesion per RECIST 1.1. For subjects who received prior locoregional therapy (e.g., transarterial (chemo)embolization, radiofrequency ablation, percutaneous injection, cryoablation, high-intensity focused ultrasound, etc.), the target lesion must not have been treated with the above locoregional therapies, or the investigator has confirmed disease progression or absence of clinical benefit in the target lesion after prior locoregional therapy.
  4. Treatment with up to one cycle of a PD-1/PD-L1 inhibitor, with or without a VEGF inhibitor, prior to enrollment is permitted.

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A&B 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
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
Other Names:
  • Part A&B ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w.
Experimental: Part C1 ABSK-011 200mg BiD combined with atilizumab and bevacizumab.
Part C1 is intended to enroll 6 subjects with advanced hepatocellular carcinoma (HCC) to receive ABSK-011 in combination with atezolizumab and bevacizumab.ABSK-011 will be administered orally at 200 mg twice daily (BID), with a single dose administered on Cycle 1 Day 1 (C1D1).
Drug: ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kg
Part C1 is intended to enroll 6 subjects with advanced hepatocellular carcinoma (HCC) to receive ABSK-011 in combination with atezolizumab and bevacizumab.ABSK-011 will be administered orally at 200 mg twice daily (BID), with a single dose administered on Cycle 1 Day 1 (C1D1).
Other Names:
  • Part C1 ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kg
Experimental: Part C2 ABSK-011 200mg BiD combined with toripalimab 240 mg + bevacizumab biosimilar 15 mg/kg

Part C2 is planned to enroll a maximum of 48 subjects with advanced HCC, divided into two stages:

Stage 1 of Part C2 intends to enroll 12 subjects with FGF19-overexpressing advanced HCC, who will be randomized 1:1 to two parallel treatment arms
Drug: ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kg

Part C2 is planned to enroll a maximum of 48 subjects with advanced HCC, divided into two stages:

tage 1 of Part C2 intends to enroll 12 subjects with FGF19-overexpressing advanced HCC, who will be randomized 1:1 to two parallel treatment arms:

Arm 1: ABSK-011 plus toripalimab plus bevacizumab biosimilar Arm 2: toripalimab plus bevacizumab biosimilar ABSK-011 will be administered orally at 200 mg BID, with a single dose administered on C1D1, and taken with food, preferably within 30 minutes after a meal. All intravenous agents will be administered on a Q3W schedule.Safety and tolerability evaluations will be performed for each treatment arm based on DLTs observed during Cycle 1 (21 days).

Stage 2 of Part C2 is planned to enroll up to 36 subjects with FGF19-overexpressing advanced HCC, randomized 1:1 to Arm 1 or Arm 2, to further characterize the efficacy and safety profile of ABSK-011 in combination with standard of care (SOC).

Other Names:
  • Part C2 ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
10 month
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
10month
To evaluate the safety and tolerability of ABSK-011 in combination with SOC in subjects with advanced or unresectable HCC, and to determine the dosing regimen for Stage 2 of Part C2.
Time Frame: 10month
Incidence of dose limiting toxicity (DLT) in the first cycle；Incidence and grade of AE, SAE and AESI by CTCAE v5.0
10month
To evaluate the preliminary efficacy of ABSK-011 in combination with toripalimab and bevacizumab in subjects with FGF19-overexpressing advanced or unresectable HCC.
Time Frame: 10month
ORR
10month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbisko Therapeutics Co, Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABSK-011-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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