Phase 1 first-in-human trial of AG01, a recombinant humanized monoclonal antibody to progranulin/glycoprotein 88 (GP88) to determine the safety, tolerability, pharmacokinetics, and preliminary antitumor activity in subjects with advanced solid tumor malignancies.

TPS2669 Background: Progranulin also called GP88/PGRN plays a major role as an autocrine growth 2) GP88 tumor expression is a prognostic indicator of recurrence 5) Elevated/rising GP88 serum levels in MBC pts are associated with disease progression DLT observation period is the 1st cycle=28days, with AGO1 Dose levels of,1mg/kg, 2mg/kg, 4mg/kg, 6mg/kg, 8 mg/kg. Initially accelerated titration design (1pt/dose level) was followed by 3+3 design). Eligibility criteria include pathologically confirmed diagnosis of advanced/relapsed/refractory solid tumor malignancy; failed >=1 SOC therapy or not a candidate/declines SOC therapy, ECOG <=2, adequate organ/bone marrow function, at least 1 RECIST 1.1 measurable and/or evaluable lesion. Tumor imaging-every 2 cycles (8 weeks) is used for response assessment. Primary objective is to determine the maximum tolerated dose MTD and/or maximum administered dose MAD of AG01 in the target population. Secondary objectives are to determine the RP2D, safety, tolerability, PKs, immunogenicity (ADA) & pts are currently enrolled. A parallel prospective study investigates the association of serum GP88 in MBC pts with response to SOC therapy and progression of disease based on RECIST 1.1 criteria. These studies are supported by NCI grants R44CA224718 and CA210817. Clinical trial information: NCT05627960 .