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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
269
IV administration of XB002
IV administration of Nivolumab
IV administration of bevacizumab
Exelixis Clinical Site #48
Birmingham, Alabama, United States
Exelixis Clinical Site #20
Tucson, Arizona, United States
Exelixis Clinical Site#95
Tucson, Arizona, United States
Exelixis Clinical Site#58
Little Rock, Arkansas, United States
Exelixis Clinical Site#59
Fountain Valley, California, United States
Dose-Escalation Stage: MTD/recommended dose for XB002
To determine the MTD and/or RD for further evaluation of IV administration of XB002 alone and in combination therapy in subjects with advanced malignancies
Time frame: 18 months
Cohort-Expansion Stage: Objective Response Rate (ORR)
To evaluate preliminary efficacy of XB002 when administered alone and in combination therapy by determining the ORR per RECIST 1.1 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator
Time frame: 12 months
Safety of XB002: Adverse Events
To evaluate the safety of XB002 through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs)
Time frame: 30 months
Tolerability of XB002 as evaluated by the duration of exposure for the study
To evaluate the tolerability of XB002 through the evaluation of duration of exposure for the study treatment
Time frame: 30 months
Tolerability of XB002 as evaluated dose intensity of the study treatment
To evaluate the tolerability of XB002 through the evaluation of dose intensity of the study treatment
Time frame: 30 months
Maximum Plasma Concentration (Cmax)
To evaluate the Cmax for XB002, total antibody, and free payload at scheduled visits over time
Time frame: 30 months
Trough Concentration (Ctrough)
To evaluate the Ctrough of XB002, total antibody, and free payload at scheduled visits over time
Time frame: 30 months
Immunogenicity of XB002
To assess the immunogenicity of XB002 as measured by anti-drug antibody (ADA) analysis
Time frame: 30 months
Anti-tumor activity of XB002: Objective Response Rate (ORR)
To evaluate the anti-tumor activity of XB002, as measured by ORR, per RECIST 1.1 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage).
Time frame: 30 months
Anti-tumor activity of XB002: Duration of Response (DOR)
To evaluate the anti-tumor activity of XB002, as measured by DOR, per RECIST 1.1 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)
Time frame: 30 months
Anti-tumor activity of XB002: Progression Free Survival (PFS)
To evaluate the anti-tumor activity of XB002, as measured by PFS, per RECIST 1.1 (or other applicable response criteria eg. RANO or PCWG3 criteria) as assessed by the Investigator (dose escalation stage) or by a BIRC for selected cohorts (cohort expansion stage)
Time frame: 30 months
Cohort-Expansion Stage: overall survival
To evaluate overall survival
Time frame: 12 months
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Exelixis Clinical Site #21
Los Angeles, California, United States
Exelixis Clinical Site #26
Los Angeles, California, United States
Exelixis Clinical Site #16
New Haven, Connecticut, United States
Exelixis Clinical Site #22
Washington D.C., District of Columbia, United States
Exelixis Clinical Site#93
Chicago, Illinois, United States
...and 85 more locations