Hepatocellular CarcinomaPhase 2NCT05441475
A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab or SOC in HCC Patients
A Phase 2 study testing ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w, ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kg and ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kg in people with Hepatocellular Carcinoma, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w, ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kg and ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2021to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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-
- 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:
- Provide archived tumor tissue samples or undergo biopsy for FGF19 overexpression testing at the central laboratory.
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- 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.
- 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.
- Treatment with up to one cycle of a PD-1/PD-L1 inhibitor, with or without a VEGF inhibitor, prior to enrollment is permitted.
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Hubei, Shanghai Municipality, 430030
About this study
Official title: 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.
Read the 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).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w, ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kg, ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kg
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK-011 180 mg QD combined with atilizumab 1200 mg q3wDrug
Also called 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
ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kgDrug
Also called Part C1 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).
ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kgDrug
Also called Part C2 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).
| Study group | Role | What they receive |
|---|---|---|
| Part A&B ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w. | Experimental | 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 Receives: Drug: ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w |
| Part C1 ABSK-011 200mg BiD combined with atilizumab and bevacizumab. | Experimental | 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). Receives: Drug: ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kg |
| Part C2 ABSK-011 200mg BiD combined with toripalimab 240 mg + bevacizumab biosimilar 15 mg/kg | Experimental | 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 Receives: Drug: ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 month
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
Measured: 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.
Incidence of dose limiting toxicity (DLT) in the first cycle；Incidence and grade of AE, SAE and AESI by CTCAE v5.0
Measured: 10month
To evaluate the preliminary efficacy of ABSK-011 in combination with toripalimab and bevacizumab in subjects with FGF19-overexpressing advanced or unresectable HCC.
ORR
Measured: 10month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start30 Dec 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A+B, Single group, ABSK-011 combined with atelizumab in the treatment of patients with advanced or unresectable HCC; Part C1, Single group,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). Part C2 ,parallel, intends to enroll 48 subjects with FGF19-overexpressing advanced HCC, who will be randomized 1:1 to two parallel treatment arms.
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441475
- Sponsor's protocol ID
- ABSK-011-201
- Status last verified
- Feb 2026
- First submitted
- 28 Jun 2022
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05441475
- Acronym / sponsor ID
- ABSK-011-201
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Part A+B, Single group, ABSK-011 combined with atelizumab in the treatment of patients with advanced or unresectable HCC; Part C1, Single group,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). Part C2 ,parallel, intends to enroll 48 subjects with FGF19-overexpressing advanced HCC, who will be randomized 1:1 to two parallel treatment arms.
| Arm | Type | Receives |
|---|---|---|
| Part A&B ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w. | Experimental | Drug: ABSK-011 180 mg QD combined with atilizumab 1200 mg q3wDuring 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 C1 ABSK-011 200mg BiD combined with atilizumab and bevacizumab. | Experimental | Drug: ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kgPart 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). |
| Part C2 ABSK-011 200mg BiD combined with toripalimab 240 mg + bevacizumab biosimilar 15 mg/kg | Experimental | Drug: ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kgPart 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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-
- 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:
Key exclusion criteria (4 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABSK-011 180 mg QD combined with atilizumab 1200 mg q3wAlso: 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 | Part A&B ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w. |
| ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kgAlso: Part C1 ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kgPart 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 | Part C1 ABSK-011 200mg BiD combined with atilizumab and bevacizumab. |
| ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kgAlso: Part C2 ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kgPart 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). | Drug | Part C2 ABSK-011 200mg BiD combined with toripalimab 240 mg + bevacizumab biosimilar 15 mg/kg |
Primary outcome
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABSK-011 180 mg QD combined with atilizumab 1200 mg q3w, ABSK-011 200mg BID combined with atilizumab 1200 mg q3w and bevacizumab 15mg/kg and ABSK-011 200mg BID combined with toripalimab 240 mg and bevacizumab biosimilar 15 mg/kg in people with Hepatocellular Carcinoma, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of ABSK-011 combined with atezolizumab mab in subjects with advanced or unresectable HCC (time frame: 10 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.