This study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
JANX008 is dosed via IV weekly in a 21-day cycle
City of Hope Medical Center
Duarte, California, United States
RECRUITINGUniversity of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGUniversity of California San Diego Moores Cancer Center
San Diego, California, United States
RECRUITINGWinship Cancer Institute, Emory University
Atlanta, Georgia, United States
RECRUITINGUniversity of Chicago Medical Center
Chicago, Illinois, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGHenry Ford Health System
Detroit, Michigan, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGLaura and Isaac Perlmutter Cancer Center NYU Langone Health
New York, New York, United States
RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITING...and 8 more locations
Incidence of Dose Limiting Toxicities (DLT)
Time frame: 21 days
Incidence of Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: Up to 4 years
Incidence of Clinically Significant Laboratory Abnormalities
Time frame: Up to 4 years
Area under the concentration time curve from time 0 to last timepoint prior to next dose JANX008 (AUC last)
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years)
Maximum observed concentration of JANX008 (Cmax)
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1, 2, 4, 8, 9, 15, 16, 18 up to end of treatment (Up to 4 years)
Number of participants who develop anti-drug antibodies against JANX008
Time frame: Up to 4 years
Overall Response Rate
Proportion of participants who achieve a complete response or partial response per RECIST v1.1
Time frame: Up to 4 years
Duration of Response
Time from documentation of CR or PR to disease progression per RECIST v1.1
Time frame: Up to 4 years
Progression Free Survival
Time from treatment initiation to disease progression per RECIST v1.1
Time frame: Up to 4 years
Correlation of EGFR expression level with anti-tumor activity and safety
Time frame: Up to 4 years
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