A Phase 1, Open-Label, Multicenter Study of Janx007 in Subjects with Metastatic Castration-Resistant Prostate Cancer
Objective
Primary Objectives (Part 1 and Part 2a): To assess safety and tolerability in subjects with mCRPC. To determine the maximum tolerated dose regimen (MTD-R) and/or maximally administered dose (MAD). To assess potential Phase 2 dose regimens and determine a recommended Phase 2 dose regimen (RP2D-R).
Secondary Objectives (Part 1 and Part 2a): To evaluate the pharmacokinetic (PK) profile of JANX007 following intravenous (IV) administration. To evaluate the immunogenicity of JANX007. To assess preliminary efficacy of JANX007
Exploratory Objectives (Part 1, Part 2 and Part 3): To evaluate the pharmacodynamic (PD) profile of JANX007 following IV administration. To characterize the impact of JANX007 on systemic immune factors, including cytokines and immune cells. To assess response by novel methods, prostate-specific membrane antigen (PSMA)-positron emission tomography (PET) evaluation, circulating, tumor cells (CTC), and circulating tumor (ctDNA) quantitation. To assess baseline and on-treatment tumor and immune biomarkers and evaluate for correlations with anti-tumor activity and safety. To assess additional preliminary efficacy of JANX007.
Primary Objectives (Part 2b): To assess the safety and tolerability of JANX007 when administered with recombinant human albumin (rHA).
Secondary Objectives (Part 2b): To evaluate the PK profile of JANX007 when administered with rHA. To evaluate the immunogenicity of JANX007. To assess preliminary efficacy of the JANX007.
Primary Objectives (Part 3a): To compare the safety and tolerability of 2 potential RP2D-Rs identified from Part 1 and Part 2. Primary Objectives (Part 3b): To assess the safety and tolerability in taxane naive subjects with mCRPC. Primary Objectives (Part 3c): To assess safety and tolerability of JANX007 when administered via central venous (CV) port.
