New bispecific antibody shows promise for unresectable liver cancer
NCT ID NCT05432492
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 Hide 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.
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- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial
- New antibody aims to preserve immune checkpoint while fighting cancer