This is a first-in-human (FIH) Phase I/II, multi-center, open-label, study of ANS02, in patients with advanced NSCLC. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS02 as monotherapy.
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
Life expectancy ≥ 12 weeks
Measurable disease per RECIST v1.1
Active infection including tuberculosis and HBV, HCV or HIV
Known active or untreated CNS metastases
Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
Participants with serious cardiovascular or cerebrovascular diseases
Single group
ANS02
Drug4 dose levels would be explored during the study.
Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Incidence of Serious Adverse Events (SAEs)
Number of patients with serious adverse events by system organ class and preferred term
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Incidence of baseline laboratory finding, ECG and vital signs changes
Measured by laboratory and vital sign variables over time including change from baseline
Pharmacokinetics of ANS02: Plasma PK concentrations
Measurement of plasma concentrations of ANS02
Pharmacokinetics of ANS02: Area under the concentration time curve (AUC)
Measurement of PK parameters: Area under the concentration time curve (AUC)
Pharmacokinetics of ANS02: Maximum plasma concentration of the study drug (C-max)
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Pharmacokinetics of ANS02: Time to maximum plasma concentration of the study drug (T-max)
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Click on the lead sponsor to view all of their trials.
