ABSK-011 for Liver Cancer

Recruiting at 11 trial locations

Overseen By Yuan Lu, Doctor

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Abbisko Therapeutics Co, Ltd

Must be taking: Anti-HBV therapy

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: CNS metastases, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABSK-011 for individuals with liver cancer. The goal is to determine the correct dosage and understand how the body processes the drug. Participants should have liver cancer that has worsened or not responded to standard treatments, specifically advanced hepatocellular carcinoma (HCC). Candidates must have a specific protein overexpressed in their cancer and no severe liver damage or other major health issues that could affect the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot use strong inhibitors or inducers of CYP3A4 (a liver enzyme) within 14 days before starting the study drug.

Is there any evidence suggesting that ABSK-011 is likely to be safe for humans?

Research has shown that ABSK-011 has a manageable safety profile, with side effects that are not too severe and can be handled well by patients. In earlier studies, ABSK-011 was tested both alone and in combination with another drug, continuing to demonstrate safety for people with liver cancer.

The drug has been tested in patients with advanced cancer, and the results support its further development. So far, the treatment appears well-tolerated, which is encouraging for those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABSK-011 for liver cancer because it offers a new approach compared to current treatments like surgery, chemotherapy, and targeted therapies. Unlike these standard options, ABSK-011 is designed to be taken either once or twice daily, potentially improving patient convenience and adherence. It also undergoes a careful dose escalation process to determine the optimal dose, which could maximize effectiveness while minimizing side effects. This novel delivery and dosing strategy could provide a fresh hope for liver cancer patients looking for more effective and manageable treatment options.

What evidence suggests that ABSK-011 might be an effective treatment for liver cancer?

Research has shown that ABSK-011 may help treat liver cancer, particularly in cases with elevated levels of the protein FGF19. In previous studies, combining ABSK-011 with atezolizumab shrank or eliminated tumors in more than half of the patients. This treatment targets the protein FGFR4, which can aid cancer spread, and may halt tumor growth. These early findings suggest that ABSK-011 could be effective for some liver cancer patients, but further research is needed to confirm its benefits. In this trial, participants will receive ABSK-011 to further evaluate its effectiveness and safety. ^{2 3 6 7 8}

Who Is on the Research Team?

Xiaoping Chen, Doctor

Principal Investigator

Tongji Hospital

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with advanced liver cancer, specifically BCLC stage B or C and a Child-Pugh score of 5-7. Participants must have measurable tumors, no severe liver symptoms like encephalopathy or ascites needing treatment, be relatively active (ECOG 0~1), and expect to live at least three more months. They need enough white blood cells and platelets and must test positive for FGF19 overexpression in their tumor.

Inclusion Criteria

Patient must have at least 1 measurable lesion (RECIST V1.1)

Platelet count (PLT) ≥75×109/L

I can provide a tissue sample for FGF19 testing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in Period

Participants receive a single dose of ABSK-011 followed by a 1-day off to assess the pharmacokinetics of the single dose

2 days

Dose Escalation

Participants receive ABSK-011 once or twice daily in repeated 28-day cycles to evaluate safety, tolerability, and pharmacokinetics

28 days per cycle

Expansion

Participants receive ABSK-011 at the recommended dose level to further evaluate safety and tolerability in patients with FGF19 overexpression advanced HCC

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after last administration

What Are the Treatments Tested in This Trial?

Interventions

• ABSK-011

Trial Overview The study tests ABSK-011's safety, tolerability, and how the body processes it in patients with advanced solid tumors. It has two parts: dose escalation to find the safe amount to give people, then expansion where more patients receive this dose to gather additional information.

How Is the Trial Designed?

Group I: ABSK-011 Experimental Treatment 1 Intervention

During the escalation part, all patients will first receive a single dose ABSK-011 (run-in period) at Day -2 and be followed by a 1-day off (2 days in all for run-in period) to access the PK of single-dose. Then, patients will continuously receive ABSK-011 once daily (QD) or twice daily (BID) in repeated 28-day cycles. Dose escalation will employ a "3+3" design except for the patient in the accelerated titration cohort. In expansion part, patients will be treated at the selected RDE dose level.

Who Is Running the Clinical Trial?

Abbisko Therapeutics Co, Ltd

Lead Sponsor

Trials

26

Recruited

1,700+

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)00319-3/fulltext

171P A phase II study of ABSK-011 plus atezolizumab in ... 220 mg BID dosing showed encouraging efficacy with an overall response rate of 55.6% (5/9) in FGF19+ HCC. The longest duration of response (DOR) among all dose ...

2. onclive.com onclive.com/view/irpagratinib-plus-atezolizumab-is-safe-and-effective-in-fgf19-advanced-hcc

Irpagratinib Plus Atezolizumab Is Safe and Effective in ... Irpagratinib combined with atezolizumab was effective and safe in both treatment-naive and ICI-exposed advanced HCC with FGF19 overexpression.

3. dailyreporter.esmo.org dailyreporter.esmo.org/esmo-gastrointestinal-cancers-congress-2025/news/combinations-show-promise-in-hepatocellular-carcinoma-populations-with-poor-prognosis

Promising results for poor prognosis hepatocellular ... Irpagratinib, a fibroblast growth factor receptor-4 (FGFR4) inhibitor, plus atezolizumab produced an overall objective response rate of 51.7% in 29 evaluable ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11081626/

Improvements in advanced hepatocellular carcinoma to ... In addition, ABSK-011, an FGFR4 small molecule inhibitor, may ameliorate the crosstalk between receptor tyrosine kinases and promote tumor ...

5. firstwordpharma.com firstwordpharma.com/story/5871102

50% ORR: Impressive Clinical Trial Data for Irpagratinib ... (Abbisko Therapeutics) announced that it has presented new phase II clinical data of its highly selective FGFR4 inhibitor irpagratinib (ABSK011) ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02562-6/fulltext

983P Updated safety and efficacy of ABSK-011 in ... ABSK-011 demonstrated a manageable safety profile and promising anti-tumor activity as a single agent. These findings support further development of ABSK-011 at ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04906434

NCT04906434 | A Study to Assess the Safety, Tolerability, ... A Phase 1, Open-Label Study of ABSK-011 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumors

8. delta.larvol.com delta.larvol.com/Products/?ProductId=14aa9a0e-9ae4-4fb4-aa05-99eebbcfedae

irpagratinib (ABSK011) / Abbisko Delicious. June 27, 2024. 50% ORR: Impressive Clinical Trial Data for Irpagratinib Combined with Atezolizumab in Advanced Hepatocellular Carcinoma Stuns ESMO-GI ...