This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined
Research Site
Changchun, Jilin, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Hangzhou, Zhejiang, China
Dose Limiting Toxicities (DLTs)
Incidence of DLTs
Time frame: Day 1 - Day 28
Adverse events
Incidence of AEs
Time frame: Day 1 - Day 28
Laboratory results
Incidence of laboratory abnormalities
Time frame: Day 1 - Day 28
Vital signs
Incidence of vital sign abnormalities
Time frame: Day 1 - Day 28
Electrocardiogram
Incidence of ECG abnormalities
Time frame: Day 1 - Day 28
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
AUC: area under the plasma concentration versus time curve for D-0316
Time frame: Day 1 through 6, Cycle Day 1-Day 15
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Cmax: maximum plasma drug concentration of D-0316
Time frame: Day 1 through 6, Cycle Day 1-Day 15
Pharmacokinetic: Time to reach the Cmax (Tmax)
tmax: Time to reach the Cmax of D-0316
Time frame: Day 1 through 6, Cycle Day 1-Day 15
Pharmacokinetic: Apparent terminal half-life (t1/2)
t1/2: apparent terminal half-life of D-0316
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 through 6, Cycle Day 1-Day 15
Antitumor activity
Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months