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

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

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

Treatments tested in this trial

  • ABSK-011

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators