NCT05441475Enrolling by invitationPhase 2
A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab or SOC in HCC Patients
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
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 28 Jun 2022
- Start date
- 30 Dec 2021
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05441475
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 118
- From 30 Dec 2021 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- history of autoimmune diseases
- have a history of the second primary malignant tumor other than HCC within 5 years before screening,
Lab values
- have a history of uncorrectable electrolyte disorders that affect serum potassium, calcium or phosphorus levels.
Other
- meningeal metastasis or central nervous system (CNS) metastasis -
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology Coordinator of this site? Confirm its status | Hubei | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.