ABSK-011 for Liver Cancer

Recruiting at 8 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 is an open-label phase 1 study with an escalation part and an expansion part.

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+