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

a study on Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
study ends around

Description

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.

Official Title

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors

Keywords

Locally Advanced or Metastatic Solid Tumors, ROS1, NTRK, ROS1/NTRK, ANS014004, ANS014004 Monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
  • Life expectancy ≥ 12 weeks
  • Measurable disease per RECIST v1.1
  • Adequate organ and marrow function as defined in the protocol
  • With a pathogenetic MET alteration or ROS1 alteration or NTRK alternation

You CAN'T join if...

  • 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

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States
  • Sarah Cannon Research Institute accepting new patients
    Denver Colorado 80218 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Avistone Biotechnology Co., Ltd.
ID
NCT06307795
Phase
Phase 1 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 63 study participants
Last Updated
Contact us about this trial