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NCT06307795 | RECRUITING | Locally Advanced or Metastatic Solid Tumors

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

Avistone Biotechnology Co., Ltd.

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.

Condition or disease

Locally Advanced or Metastatic Solid Tumors

Intervention/treatment

ANS014004

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 63 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-06-24
Estimated Primary Completion Date : 2027-04
Estimated Study Completion Date : 2027-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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 (including MET mutation, MET amplification, MET overexpression, MET fusion)
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
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors

Location Details

NCT06307795

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Research Site

San Diego, California, United States, 92093

RECRUITING

United States, Colorado

Sarah Cannon Research Institute

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

Advent Health

Orlando, florida, United States, 32804

RECRUITING

United States, road cancer

Research Site

Detroit, road cancer, United States, 48202

RECRUITING

United States, New York

research site

New York, New York, United States, 10003

RECRUITING

United States, Texas

The University of Texas - MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

NEXT Oncology, Virginia

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Washington

Research Site

Seattle, Washington, United States, 98195