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New bispecific antibody shows promise for unresectable liver cancer

NCT ID NCT05432492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tested a drug called AK112 in 40 people with advanced liver cancer that could not be removed by surgery. AK112 is a bispecific antibody that targets two proteins (PD-1 and VEGF) involved in cancer growth. The study measured safety and how well the drug shrank tumors. Results will help determine if larger studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AK112 (a bispecific antibody targeting PD-1 and VEGF)
What this could lead to
If successful, this could offer a new treatment option for people with advanced liver cancer that cannot be surgically removed.
What could go wrong
This is a small, early-phase trial (40 patients) focused on safety and initial effectiveness. Results may not confirm benefit, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

40 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). * 18 to 75 years old. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Have a life expectancy of at least 3 months. * BCLC stage B or C, not amenable to curative surgery. * Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD). * At least one measurable untreated lesion. * Child-Pugh class A. * Has adequate organ function. * All female and male 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. Exclusion Criteria: * With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues. * History of malignancy other than HCC within 5 years, except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Have a history of hepatic encephalopathy or have a history of liver transplantation. * With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion. * Central nervous system (CNS) metastasis or meningeal metastasis. * Prior immunotherapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways). * Prior systemic bevacizumab and its analogues treatment. * Severe bleeding tendency or coagulation dysfunction; occurred arteriovenous thromboembolic events or bleeding events due to esophageal and/or gastric varices within 6 months before the first administration. * Known presence or history of required hormone treatment interstitial lung disease or non-infectious pneumonitis. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has undergone major surgery within 30 days prior to the first dose of study treatment. * History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.