This is a Phase 1/2 open label study consisting of dose escalation cohorts (Phase 1) followed by expansion cohorts (Phase 2). The Phase 1 dose escalation population includes subjects with advanced solid tumors that are refractory to standard of care therapy or for whom no standard of care options are available. Once the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of single agent LCB02A is determined, the study will proceed to Phase 2 expansion cohorts in selected tumor types.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
191
CLDN18.2-directed human monoclonal antibody (Ab) linked to a topoisomerase I inhibiting payload.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
Seoul National University Hospital
Seoul, South Korea
Safety of LCB02A (Phase 1 and 2)
Incidence and severity of AEs
Time frame: Up to 48 months
Recommended Phase 2 dose of LCB02A (Phase 1)
Based on tolerability, preliminary anti-tumor activity, and pharmacokinetics
Time frame: Up to 24 months
Objective response rate (Phase 2)
Assessed by RECIST 1.1
Time frame: Up to 24 months
Plasma concentrations of LCB02A (Phase 1 and 2)
Pharmacokinetic parameters will be determined from observed concentrations of LCB02A
Time frame: Up to 48 months
Duration of Response (Phase 1 and 2)
Assessed by RECIST v1.1
Time frame: Up to 48 months
Disease control rate (Phase 1 and Phase 2)
Assessed by RECIST v1.1
Time frame: Up to 48 months
Progression Free Survival (Phase 1 and Phase 2)
Assessed by RECIST v1.1
Time frame: Up to 48 months
Overall Survival (Phase 1 and Phase 2)
Time frame: Up to 48 months
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ASAN Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea