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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

About the study

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.

What is being tested

Sponsor: Avistone Biotechnology Co., Ltd. · Participants: 63 · Started: Jun 24, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06307795

Locations in the U.S.

CaliforniaUniversity of California, San Diego, San Diego
ColoradoSarah Cannon Research Institute, Denver
FloridaAdvent Health, Orlando
MichiganHenry Ford Health Cancer, Detroit
New YorkNYU Langone Health, New York
TexasThe University of Texas - MD Anderson Cancer Center, Houston
VirginiaNEXT Oncology, Virginia, Fairfax
WashingtonSwedish Cancer Institute, Seattle

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.