JTX-4014-101 is a Phase 1, open label, dose escalation clinical study of JTX-4014 in adult subjects with advanced refractory solid tumor malignancies, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
JTX-4014 is a fully human IgG4 monoclonal antibody designed to specifically bind to PD-1 and block its interaction with its ligands, PD-L1 and PD-L2, to augment anti-tumor T cell activity. This is a Phase 1, first in human, open label, multicenter, dose escalation clinical study to evaluate the safety, tolerability, and PK of JTX-4014 when administered as a single agent to adult subjects with advanced refractory solid tumor malignancies. The intent of this study will be to determine the MTD and RP2D.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Specified dose on specified days
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Florida Cancer Specialists - Sarasota Cattlemen
Sarasota, Florida, United States
START Midwest - Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
% subjects with adverse events (AEs)
Time frame: Approximately 12 months
% subjects with serious adverse events (SAEs)
Time frame: Approximately 12 months
% subjects with dose-limiting toxicities (DLTs)
Time frame: Approximately 12 months
% subjects with changes from baseline in pro-inflammatory cytokines
Time frame: Approximately 12 months
% subjects with clinically significant change from baseline in clinical laboratory tests
Time frame: Approximately 12 months
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JTX-4014
Time frame: Approximately 12 months
Maximum measured concentration in serum (Cmax)
Time frame: Approximately 12 months
Time from dosing to Cmax (Tmax)
Time frame: Approximately 12 months
Area under the serum concentration-time curve (AUC)
Time frame: Approximately 12 months
Last measurable concentration (Clast)
Time frame: Approximately 12 months
Time to last measurable concentration (Tlast)
Time frame: Approximately 12 months
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Terminal half-life (t1/2)
Time frame: Approximately 12 months
Accumulation ratio of JTX-4014
Time frame: Approximately 12 months
Evaluate anti-drug antibodies (ADA) against JTX-4014
Time frame: Approximately 12 months