This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]); and the dose expansion stage is to evaluate the preliminary antitumor activity of XB628 as a single agent and in combination with zanzalintinib.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
303
Intravenous infusion(s)
Oral tablet(s)
Exelixis Clinical Site #5
San Francisco, California, United States
RECRUITINGExelixis Clinical Site #4
New Haven, Connecticut, United States
RECRUITINGExelixis Clinical Site #8
Tampa, Florida, United States
RECRUITINGExelixis Clinical Site #10
Boston, Massachusetts, United States
RECRUITINGExelixis Clinical Site #11
Boston, Massachusetts, United States
RECRUITINGExelixis Clinical Site #6
St Louis, Missouri, United States
RECRUITINGExelixis Clinical Site #7
New York, New York, United States
RECRUITINGExelixis Clinical Site #1
Hickory, North Carolina, United States
RECRUITINGExelixis Clinical Site #3
Nashville, Tennessee, United States
RECRUITINGExelixis Clinical Site #9
Houston, Texas, United States
RECRUITING...and 1 more locations
Dose Escalation Cohort: Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 21 days
Dose Escalation Cohort: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 27 months
Dose Expansion Cohort: Objective Response Rate (ORR)
Time frame: Up to 27 months
Area Under the Concentration-time Curve (AUC) of XB628
Time frame: 25 months
Maximum Plasma Concentration (Cmax) of XB628
Time frame: 25 months
Time to Maximum Concentration (Tmax) of XB628
Time frame: 25 months
Elimination Half-life (T1/2) of XB628
Time frame: 25 months
Apparent Clearance (CL/F) of XB628
Time frame: 25 months
Trough Concentration (Ctrough) of XB628
Time frame: 25 months
Number of Participants with Antidrug Antibody (ADA) Response to XB628
Time frame: 25 months
RDE for XB628
Time frame: 25 months
Dose Expansion Cohort: Duration of Response (DOR)
Time frame: 27 months
Dose Expansion Cohort: Progression-Free Survival (PFS) of XB628
Time frame: 27 months
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