This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation study of ABL103 to evaluate the safety, tolerability, MTD (maximum tolerated dose) and/or RP2D (recommended phase 2 dose), pharmacokinetics, immunogenicity, preliminary antitumor activity of ABL103 in subjects with any progressive locally advanced(unresectable) or metastatic solid tumor who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 2 parts: a dose-escalation part and tumor-expansion part
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
96
ABL103 will be administered biweekly of every 28-day cycle in the dose-escalation. The dosing interval to be used in tumor-expansion part will be evaluated based on the emerging safety and PK data from the dose-escalation part of the study.
Seoul National University Bundang Hospital
Seongnam, Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, Seoul, South Korea
NOT_YET_RECRUITINGSevrance Hospital
Seoul, South Korea, South Korea
RECRUITINGNumber of subjects with Dose-Limiting Toxicities (DLT)
Number of subjects with Dose-Limiting Toxicities (DLT)
Time frame: From Day 1 until disease progression or Day 28
Number of subjects with Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and immune-related Adverse Events (irAEs)
Number of subjects with Treatment-emergent AEs, SAEs and irAEs
Time frame: From Day 1 until confirmed Complete Response (CR), disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first
Number of subjects with Treatment-emergent Infusion related reactions (IRRs)
Number of subjects with Treatment-emergent IRRs
Time frame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first
Number of subjects with the changes from baseline in laboratory values
Number of subjects with the changes from baseline in laboratory values
Time frame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first
Pharmacokinetic profile of ABL103
serum concentration of ABL103 will be collected and analyzed to evaluate the PK of ABL103
Time frame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable toxicity, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to 24 months
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