Perlmutter Cancer Center

This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors. This study consists of Dose-Escalation and Cohort-Expansion Stages for the evaluation of XB002 as monotherapy and in combination with nivolumab or bevacizumab. First, the safety and PK of XB002 monotherapy will be evaluated in the Single-Agent Dose-Escalation Stage. In this stage, subjects with advanced solid tumors will be treated with XB002 in dose-escalation cohorts using the i3+3 design (Liu et al 2020). Dose-escalation steps of XB002 will be tailored by monitoring safety and PK data. The safety and PK of XB002 combination therapy will be evaluated in the Combination Therapy Cohort-Expansion Stage for nivolumab or bevacizumab. A Cohort Review Committee (described in Section 3.7.1) will determine the MTD and the RD of XB002 from both Dose Escalation Stages (single-agent XB002 and in combination with nivolumab or bevacizumab) for use in the corresponding Cohort-Expansion Stages. After the RD of XB002 has been identified in the Dose-Escalation Stage, safety and efficacy of XB002, both as a single agent and in combination with nivolumab or bevacizumab, may be further evaluated in the Cohort-Expansion Stage. The opening of each expansion cohort will be determined by the Sponsor. The TA TF+ cohort may be opened at selected sites and/or countries. An overview of the study design is provided in the schematic below (Figure 1) and summaries of planned enrollment for the study are shown in Table 1.