Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
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
  • Swedish Cancer Institute accepting new patients
    Seattle Washington 98195 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