A Phase I, Open-Label, Dose Finding Study To Assess The Safety, Tolerability, Pharmacokinetics, And Preliminary Efficacy Of OBT076, A CD205-Directed Antibody-Drug Conjugate, In Recurrent And/Or Metastatic CD205 Positive Solid Tumors And In Women With CD205 Positive HER2-Negative Metastatic Breast Cancer
This is a Phase I research study designed to look at several dose levels of the study drug to find the highest dose level that is safe and well-tolerated (does not cause unacceptable side effects), and to examine the effects of the study drug in a small group of research participants. The study will also look at the effectiveness of OBT076 as an anti-cancer therapy. Once the optimal dose is determined and safety is assessed, additional research participants will be treated at the optimal dose level to further evaluate safety and effectiveness
Primary Objectives: To evaluate the safety and tolerability of OBT076 To define the MTD and/or the RP2D of OBT076 Secondary Objectives: To provide preliminary efficacy data on OBT076 To characterize the PK parameters of OBT076 Exploratory Objectives: To explore potential PD parameters of OBT076: To determine the correlation of TApDC presence and clinical activity of OBT076 To establish correlations, through immuno-monitoring in peripheral blood samples, that can be used for response prediction and/or biomarker definition To evaluate the target antigen expression (CD205) in archival biopsy and fresh biopsy in at least 10 subjects to compare expression levels over time
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