A Phase 1 Study of XB628 in Participants With Recurrent Advanced or Metastatic Solid Tumors
Summary
This is a phase 1, first-in-human, open-label, dose-escalation study of XB628, a first-in-class bispecific antibody natural killer (NK) cell engager that targets NK group 2 member A (NKG2A), an inhibitory receptor on NK cells, and programmed cell death-ligand 1 (PD-L1).
Detailed description
This study consists of a Dose-Escalation Stage. The Dose-Escalation Stage is designed to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE\[s\]) of XB628 as a single agent.
Arms & interventions
- BiologicalXB628
Intravenous infusion(s)
Outcome measures
Primary
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: 21 days
Number of Participants with Serious Adverse Events (SAEs), Treatment-emergent Adverse Events (TEAEs), and Adverse Events (AEs) Leading to Dose Withholding, Treatment Discontinuation, or Death
Time frame: 27 months
Secondary
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
Objective Response Rate (ORR)
Time frame: 27 months
Duration of Response (DOR)
Time frame: 27 months
RDE for XB628
Time frame: 25 months
Eligibility criteria
Study locations (11)
Exelixis Clinical Site #5
San Francisco, California, 94158
Exelixis Clinical Site #4
New Haven, Connecticut, 06520
Exelixis Clinical Site #8
Tampa, Florida, 33612
Exelixis Clinical Site #10
Boston, Massachusetts, 02114
Exelixis Clinical Site #11
Boston, Massachusetts, 02114
Exelixis Clinical Site #6
St Louis, Missouri, 63108
Exelixis Clinical Site #7
New York, New York, 10029
Exelixis Clinical Site #1
Hickory, North Carolina, 28602
Exelixis Clinical Site #3
Nashville, Tennessee, 37203
Exelixis Clinical Site #9
Houston, Texas, 77030
Exelixis Clinical Site #2
San Antonio, Texas, 78229