Recruiting
Phase 1

ANS014004

Sponsor:

Avistone Biotechnology Co., Ltd.

Code:

NCT06307795

Conditions

Locally Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ANS014004

Study Details

Brief 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.

Conditions

Locally Advanced or Metastatic Solid Tumors

Study ID

NCT06307795

Start date

Jun 24, 2024

Status verified date

Apr, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

63 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ANS014004 Monotherapy

Part 1 aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of ANS014004.

Part 2 aims to determine the safety, tolerability and evaluate anti-tumor activity of ANS014004 as monotherapy in select solid tumors.

Interventions

ANS014004

Varying doses of ANS014004

Primary outcome measure

  • Incidence of Adverse Events (AEs) [ Time Frame: From the time of first dose to 28 days post last dose of ANS014004 ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: From time of first dose to 28 days post last dose of ANS014004 ]
  • Incidence of dose-limiting toxicities (DLT) as defined in the protocol [ Time Frame: From time of first dose of ANS014004 to end of DLT period (approximately 30 days) ]
  • Incidence of baseline laboratory finding, ECG and vital signs changes [ Time Frame: From time of first dose to 28 days post last dose of ANS014004 ]
  • Proportion of patients with radiological response (ORR) [ Time Frame: From date of first dose of ANS014004 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)） ]

Central Contacts and Locations

Central contacts

Avistone Clinical Study Information Center

8610 84148921information.center@avistonebio.com

Locations

University of California, San Diego

Recruiting

San Diego, California, United States, 92093

Sarah Cannon Research Institute

Recruiting

Denver, Colorado, United States, 80218

Advent Health

Recruiting

Orlando, Florida, United States, 32804

Henry Ford Health Cancer

Recruiting

Detroit, Michigan, United States, 48202

NYU Langone Health

Recruiting

New York, New York, United States, 10003

The University of Texas - MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Oncology, Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98195

BC Cancer Vancouver Centre

Recruiting

Vancouver, British Columbia, Canada

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Avistone Biotechnology Co., Ltd.

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • ROS1
  • NTRK
  • ROS1/NTRK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Avistone Biotechnology Co., Ltd. on 2026-04-17.