This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 3 parts: a dose-escalation part, a dose-expansion part and tumor-expansion part
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
ABL503 will be administered intravenously (IV) on Day 1 and Day 15 of every 28-day cycle in the dose-escalation part. The dosing interval to be used in the dose-expansion part will be re-evaluated based on the emerging safety and PK data from the dose-escalation part of the study.
City of Hope
Duarte, California, United States
RECRUITINGUSC
Los Angeles, California, United States
RECRUITINGUCLA
Santa Monica, California, United States
RECRUITINGSarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGNumber of Subjects with Dose-Limiting Toxicities (DLT)
Number of subjects with Dose-Limiting Toxicity (DLT)
Time frame: From Day 1 until disease progression or Day 28, whichever came first
Number of subjects with AE, IrAEs, IRRs, SAEs and abnormalities in Lab
Number of subjects with Adverse Event, Immune-related Adverse Event, Infusion-related Reactions (IRRs), serious AEs, and abnormalities in lab parameters
Time frame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months
Objective Response Rate (ORR)
Proportion of subject with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1
Time frame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months
Pharmacokinetic (PK) of ABL503
Serum concentrations of ABL503 will be collected and analyzed to evaluate the PK of ABL503
Time frame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months
Immunogenicity of ABL503
Incidence of anti-ABL503 antibody will be analyzed to evaluate the Immunogenicity of ABL503
Time frame: From Day 1 until confirmed CR, disease progression, initiation of a new anticancer therapy, unacceptable AEs, or subject's consent withdrawal, or investigator's decision to discontinue treatment, which came first, assessed up to approx. 12 months
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