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Hepatocellular CarcinomaPhase 1/2NCT06530251

A Study of AK112 in Patients With Advanced Hepatocellular Carcinoma (HCC)

A Phase 1/2 study testing AK112, Cadonilimab and AK127 in people with Hepatocellular Carcinoma, run by Akeso at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

There're 2 parts in this interventional study: 1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK112 in combination therapies for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
AK112, Cadonilimab and AK127
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
2 sitesChina
Study dates
24 Sep 2024to Sep 2028
Phase
Phase 1/2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Be able and willing to provide written informed consent.
  • Have a life expectancy of at least 3 months.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • HCC confirmed by histology/cytology or confirmed by the American Society for the Study of Hepatology (AASLD) clinical diagnostic criteria for hepatocellular carcinoma in patients with cirrhosis.
  • Phase Ib:
  • Barcelona Clinical Liver Cancer (BCLC) stage B or C.
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  • Has failed standard treatment and has received no more than two lines of anti-tumor treatment in the past;
  • Phase II:
  • The BCLC staging is stage C, which is not suitable for curative and local treatment, or for stage B that cannot be cured after curative and/or local treatment.
  • Subjects who have not received any systematic anti-tumor treatment for HCC in the past.
  • According to RECIST v1.1, there is at least one untreatable measurable lesion, or a measurable lesion with clear imaging progression after local treatment, suitable for repeated and accurate measurement.
  • Liver function grading Child Pugh Grade A.
  • Has adequate organ function.
  • All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.
  • Able to to comply with all requirements of study participation (including all study procedures).

Who cannot join

  • Components confirmed by histology/cytology, such as fibrous layer hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and cholangiocarcinoma.
  • Except for HCC, the subjects had other malignant tumors within the 5 years prior to enrollment. Subjects with other malignant tumors that have been cured through local treatment are not excluded, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast cancer in situ. If diagnosed with liver cancer or other malignant tumors more than 5 years before administration, pathological or cytological diagnosis of recurrent and metastatic lesions is required.
  • Tumor volume>50% liver volume; Portal vein cancer thrombus (Vp4), inferior vena cava cancer thrombus.
  • Tumors invade important organs and blood vessels around them, and researchers have determined that entering the study will cause a higher risk of bleeding.
  • There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis.
  • There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage.
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  • Previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, and any other treatments targeting the immune mechanisms of tumors.
  • Received local treatment for the liver within 4 weeks prior to the first administration; Received palliative radiotherapy for non liver patients within 2 weeks prior to initial administration.
  • There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment, or current lung diseases including but not limited to interstitial lung disease, pneumoconiosis, silicosis, drug-related pneumonia, and severely impaired lung function.
  • History of severe bleeding tendency or coagulation dysfunction.
  • Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia.
  • Any arterial or venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred within 6 months prior to the first administration of medication.
  • Pregnant or lactating female subject.
  • Any prior or concurrent disease, treatment, or laboratory test abnormality that may confuse study results, affect subjects' full participation in the study, or may not be in their best interest to participate.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Wenting Li contact

18116403289

wenting01.li@akesobio.com

China2 sites, 2 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Jianqiang Cai

    Recruiting

  • Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

    Jinan, Shandong

    Jinming Yu

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Study of AK112 in Combination Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC)

There're 2 parts in this interventional study:

  1. The goal of phase Ib trial is to evaluate the safety and tolerability of AK112 in combination therapies for the purpose of observing the incidence of dose limit toxicity (DLT) as well as the confirmation of maximum tolerable dose (MTD) in the treatment of advanced hepatocellular carcinoma (HCC), so as to determine the recommended phase 2 dose (RP2D) in the second part of the trial.
  2. The goal of phase II trial is to evaluate the safety and efficacy of AK112 in combination therapy or monotherapy in the treatment of HCC compared to the combination of Sintilimab and Bevacizumab biosimilar.
Being tested
AK112, Cadonilimab, AK127, AK130, Sintilimab Injection
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK112Drug

    Following a predefined dose and date.

  • CadonilimabDrug

    Following a predefined dose and date.

  • AK127Drug

    Following a predefined dose and date.

  • AK130Drug

    Following a predefined dose and date.

  • Sintilimab InjectionDrug

    Following the local label direction.

  • Bevacizumab biosimilarDrug

    Following the local label direction.

Study groups in NCT06530251
Study groupRoleWhat they receive
AK112 in combination with AK130ExperimentalNot described
Receives: Drug: AK112; Drug: AK130
AK112 in combination with AK127ExperimentalNot described
Receives: Drug: AK112; Drug: AK127
AK112 in combination with CadonilimabExperimentalNot described
Receives: Drug: AK112; Drug: Cadonilimab
AK112ExperimentalNot described
Receives: Drug: AK112
Sintilimab in combination with Bevacizumab biosimilarActive comparatorNot described
Receives: Drug: Sintilimab Injection; Drug: Bevacizumab biosimilar

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of subjects with dose limiting toxicities (DLTs)

    DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.

    Measured: During the first three weeks.

  2. Number of subjects with adverse events (AEs)

    AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

    Measured: From the time of informed consent signed through 90 days after the last dose of study drug.

  3. Objective Response Rate (ORR) (Phase II)

    ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).

    Measured: Up to approximately 2 years.

Secondary outcomes (7)

  1. Objective Response Rate (ORR) (Phase Ib)

    ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).

    Measured: Up to approximately 2 years.

  2. Objective Response Rate (ORR) Per mRECIST

    ORR is defined as the proportion of subjects with BOR response of CR or PR (based on mRECIST).

    Measured: Up to approximately 2 years.

  3. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with response of CR, PR and SD (based on RECIST Version 1.1).

    Measured: Up to approximately 2 years.

  4. Duration of Response (DoR)

    The time from first documented evidence of CR or PR until time of first documented disease progression.

    Measured: Up to approximately 2 years.

  5. Progression Free Survival (PFS)

    PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause.

    Measured: Up to approximately 2 years.

  6. Time to response (TTR)

    Time between date of start of treatment until first documented response (CR or PR).

    Measured: Up to approximately 2 years

  7. Overall survival (OS)

    OS is defined as the time from first dose until death due to any cause

    Measured: From baseline until death due to any cause.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start24 Sep 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06530251
Sponsor's protocol ID
AK112-209
Status last verified
Mar 2026
First submitted
28 Jul 2024
Last updated
4 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AK112, Cadonilimab and AK127 in people with Hepatocellular Carcinoma, run by Akeso at 2 sites 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 15 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Wenting Li (18116403289, wenting01.li@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with dose limiting toxicities (DLTs) (time frame: During the first three weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06530251.

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 4 Mar 2026.

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