A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

ANS014004: Varying doses of ANS014004

Study summary

This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.

Eligibility

Primary outcome measure(s)

• Incidence of Adverse Events (AEs) — From the time of first dose to 28 days post last dose of ANS014004
  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 ANS014004
  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 ANS014004 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 ANS014004
  measured by laboratory and vital sign variables over time including change from
• Proportion of patients with radiological response (ORR) — From date of first dose of ANS014004 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 (15)

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