A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN1)
Summary
This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.
Detailed description
The study includes two parts: Part A (dose escalation) and Part B (dose expansion). In Part A, locally advanced or metastatic NSCLC patients with EGFR mutations following at least 1 prior EGFR TKI regimen will be enrolled. In Part B, locally advanced or metastatic NSCLC patients with EGFR sensitizing mutations, who are previously treated with 1 line of third-generation of EGFR TKI treatment as well as treatment naïve will be enrolled.
Arms & interventions
- DrugDZD6008
Daily dose of DZD6008
- DrugSunvozertinib
Daily dose of Sunvozertinib
Outcome measures
Primary
Part A: To assess safety and tolerability
Number of participants with Dose-limiting Toxicities (DLTs)
Time frame: 21 days after the first multiple dose
Part A: To assess safety and tolerability
Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)
Time frame: Through the study completion, an average of around 1 year
Part B: To assess anti-tumor activity
Objective Response Rate (ORR) assessed by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Through the study completion, an average of around 1 year
Secondary
Part A: To characterize the plasma concentration of DZD6008 following single and multiple oral dose administration
Time frame: From first dosing to cycle 7 day 1, each cycle is 21 days
Part A: To characterize the plasma concentration of sunvozertinib and metabolite DZ0753 following single and multiple oral dose administration
Time frame: From first dosing to cycle 9 day 1, each cycle is 21 days
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 1 year
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 1 year
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 1 year
Part B: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 1 year
Part B: To assess the anti-tumor activity
Time frame: PFS assessed by investigators per RECIST version 1.1
Part B: Plasma concentration of DZD6008
Time frame: Time Frame: From first dosing to cycle 11 day 1, each cycle is 21 days
Part B: To assess safety and tolerability
Time frame: Through the study completion, an average of around 1 year
Eligibility criteria
Study locations (3)
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Virginia Cancer Specialist (NEXT Oncology-Virginia)
Fairfax, Virginia, 22031