This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of NX-019 and preliminary efficacy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutant cancer.
Part 1: The primary objective of Part 1 of this study is to evaluate the safety and tolerability of NX-019 and to determine the maximum tolerated dose (MTD)/Recommended Expansion Dose(s) (REDs). Part 2: The primary objective of Part 2 of this study is to confirm the safety and tolerability of NX-019 at the REDs and, for each expansion cohort, the preliminary evidence of efficacy as measured by objective response rate (ORR).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
258
NX-019 will be administered orally.
City of Hope Comprehensive Cancer Center - Duarte
Duarte, California, United States
City of Hope - Seacliff
Huntington Beach, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
Part 1 and Part 2: Incidence of Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 4.5 years
Part 1 and Part 2: Incidence of Adverse Events of Special Interest (AESIs)
Time frame: Up to 4.5 years
Part 1 and Part 2: Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 4.5 years
Part 2: Objective Response Rate
Time frame: Up to 4.5 years
Part 1: Progression-free Survival (PFS)
Time frame: Up to 4.5 years
Part 1: Objective Response Rate of NX-019
Time frame: Up to 4.5 years
Part 1 and Part 2: Plasma Concentration of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Cerebrospinal Fluid (CSF) Concentration of NX-019
Time frame: Up to 43 days
Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Area Under the Concentration Versus Time Curve (AUC) Over a Dosing interval (AUCtau) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
HealthPartners Frauenshuh Cancer Center
Saint Louis Park, Minnesota, United States
HealthPartners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States
University Of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, United States
NEXT Virginia
Fairfax, Virginia, United States
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
...and 2 more locations
Part 1 and Part 2: AUC from Time 0 to the Time of Last Quantifiable Plasma Concentration (AUC0-t) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: AUC from Time 0 to Infinity (AUC0-inf) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Percent of AUC Extrapolated (AUC%extrap) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Terminal Phase Elimination Half-life (t½) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Terminal Phase Elimination Rate Constant (λz) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Apparent Plasma Clearance (CL/F) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Apparent Volume of Distribution (Vd/F) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Accumulation Index Using Cmax (AICmax) and Accumulation Index Using AUC (AIAUC0-inf) of NX-019
Time frame: Day 1, 2, and 15 of Cycle 1, Day 1 and 15 of Cycle 2, Day 1 of Cycle 3 and every odd-numbered Cycle thereafter (1 Cycle is 28 days)
Part 1 and Part 2: Time to Response (TTR)
Time frame: Up to 4.5 years
Part 1 and Part 2: Duration of Response (DOR)
Time frame: Up to 4.5 years
Part 1 and Part 2: Disease Control Rate (DCR)
Time frame: Up to 4.5 years
Part 1 and Part 2: Overall Survival (OS)
Time frame: Up to 4.5 years
Part 1 and Part 2: Objective Response Rate for CNS (central nervous system) Metastases
Time frame: Up to 4.5 years
Part 1 and Part 2: TTR for CNS (central nervous system) Metastases
Time frame: Up to 4.5 years
Part 1 and Part 2: DOR for CNS (central nervous system) Metastases
Time frame: Up to 4.5 years