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A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor

ConditionAdvanced Liver Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAbbisko Therapeutics Co, Ltd

About this trial

This is an open-label phase 1 study with an escalation part and an expansion part.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, age 18 ~ 75 (include both ends, or other age range required by local regulations or IRB).

BCLC stage B or C and Child-Pugh score 5~6

Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing

Patient must provide archived tissue sample or biopsy for FGF19 overexpression central lab testing, and the result must be positive

Disqualifiers

Known allergy or hypersensitivity to any component of the investigational drug product.

Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitors should be confirmed with the sponsor).

Has a known second primary malignancy required active treatment.

Has a known active central nervous system (CNS) metastases (if stable disease after treatment, free from or daily dexamethasone <10 mg or other equivalent glucocorticoids can be enrolled).

Trial design

Design model

Sequential

Treatments tested in this trial

  • ABSK-011

    Drug

    During the escalation part, the administration of oral ABSK-011 will be guided by "3+3"design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data. A separate food effect cohort may be conducted. In expansion part, patients will be treated at the selected RDE dose level.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: ABSK-011Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of DLT

Incidence of dose-limiting toxicities (DLTs) in Cycle 1

Time frame
From the starting dosing of study drug to the end of Cycle 1 (each cycle is 28 days) in escalation Part
2

Incidence and severity of AEs, AESIs and SAEs

Incidence and severity of adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs) (Common Terminology Criteria for Adverse Events, CTCAE 5.0)

Time frame
30 days after last administration, an average of one half year
3

dose reduction or discontinuation

dose reduction or discontinuation of study drug due to toxicity

Time frame
through study completion, an average of one half year
4

physical examinations changes from baseline

BMI

Time frame
through study completion, an average of one half year

Secondary outcomes

1

Cmax

maximum observed concentration (Cmax)

Time frame
the end of Cycle 1 Day15 (each cycle is 28 days)
2

Tmax

time to maximum observed concentration (Tmax)

Time frame
the end of Cycle 1 Day15 (each cycle is 28 days)
3

AUC

area under the concentration-time curve (AUC)

Time frame
the end of Cycle 1 Day15 (each cycle is 28 days)
4

t1/2β

elimination half-life (t1/2β)

Time frame
the end of Cycle 1 Day15 (each cycle is 28 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbisko Therapeutics Co, Ltd

Lead sponsor

Source ClinicalTrials.gov
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