This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating, including uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be enrolled into one of 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
Furmonertinib tablet
Furmonertinib tablet
Furmonertinib tablet
Furmonertinib tablet
Furmonertinib tablet
ArriVent Investigative Site
Prescott, Arizona, United States
ArriVent Investigative Site
Sacramento, California, United States
ArriVent Investigative Site
Whittier, California, United States
ArriVent Investigative Site
Celebration, Florida, United States
ArriVent Investigative Site
Detroit, Michigan, United States
Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib
Time frame: Up to 36 months after first dose
Stage 2: Overall Response Rate (ORR)
Time frame: Up to 36 months after first dose
Stage 1: Overall Response Rate
Time frame: Up to 36 months after first dose
Stage 1: Duration of Response (DOR)
Time frame: Up to 36 months after first dose
Stage 1: Disease Control Rate
Time frame: Up to 36 months after first dose
Stage 1: Progression Free Survival
Time frame: Up to 36 months after first dose
Stage 1: Depth of Response
Time frame: Up to 36 months after first dose
Stage 1: Overall survival
Time frame: Up to 36 months after first dose
Stage 1: Central Nervous System ORR
Time frame: Up to 36 months after first dose
Stage 1: Central Nervous System DOR
Time frame: Up to 36 months after first dose
Stage 1: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time frame: Up to 36 months after first dose
Stage 1, Cohort 1, Backfill only: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time frame: Up to 36 months after first dose
Stage 1, Cohort 1, Backfill only: Plasma concentrations of midazolam and its metabolite (1-OH-midazolam)
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Duration of Response
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Disease Control Rate
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Progression Free Survival
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Depth of Response
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Overall survival
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Central Nervous System ORR
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Central Nervous System DOR
Time frame: Up to 36 months after first dose
Stage 2, Cohort 4 only: Overall Response Rate
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Number of incidence and severity of AEs as a measure of safety and tolerability of Furmonertinib
Time frame: Up to 36 months after first dose
Stage 2, all cohorts: Plasma concentrations of furmonertinib and its major metabolite (AST5902)
Time frame: Up to 36 months after first dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ArriVent Investigative Site
Houston, Texas, United States
ArriVent Investigative Site
Fairfax, Virginia, United States
ArriVent Investigative Site
Blacktown, New South Wales, Australia
ArriVent Investigative Site
St Leonards, New South Wales, Australia
ArriVent Investigative Site
Heidelberg, Victoria, Australia
...and 32 more locations