A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

ANS03: ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).

Study summary

This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 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 ANS03
  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 ANS03
  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 ANS03 to end of DLT period (approximately 30 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 ANS03
  measured by laboratory and vital sign variables over time including change from baseline
• Proportion of patients with radiological response (ORR) — From date of first dose of ANS03 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)
  Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1

Trial sites (5)

More Avistone Biotechnology Co., Ltd. trials in China