A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

ANS02: 4 dose levels would be explored during the study.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Incidence of Adverse Events (AEs) — From the time of first dose to 28 days post last dose of ANS02
  Number of patients with adverse events by system organ class and preferred term
• Incidence of Serious Adverse Events (SAEs) — From time of first dose to 28 days post last dose of ANS02
  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 — From time of first dose of ANS02 to end of DLT period (approximately 28 days)
  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 — From time of first dose to 28 days post last dose of ANS02
  Measured by laboratory and vital sign variables over time including change from baseline

Trial sites (5)

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