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Recruiting Phase 1 NCT06307795

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

Phase 1 – testing safety in a small group of people
Conditions: Locally Advanced or Metastatic Solid Tumors

Sponsor: Avistone Biotechnology Co., Ltd.

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
ANS014004
DRUG
Locations 15
Canada (2)
Princess Margaret Cancer Centre
Toronto , Ontario
BC Cancer Vancouver Centre
Vancouver , British Columbia
China (5)
Beijing Chest Hospital
Beijing , Beijing Municipality
NOT_YET_RECRUITING
Harbin Medical University Cancer Hospital
Harbin , Heilongjiang
NOT_YET_RECRUITING
Shandong Cancer Hospital
Jinan , Shandong
NOT_YET_RECRUITING
Shanghai Chest Hospital
Shanghai , Shanghai Municipality
NOT_YET_RECRUITING
Henan Cancer Hospital
Zhengzhou , Henan
NOT_YET_RECRUITING
United States (8)
Sarah Cannon Research Institute
Denver , Colorado
Henry Ford Health Cancer
Detroit , Michigan
NEXT Oncology, Virginia
Fairfax , Virginia
The University of Texas - MD Anderson Cancer Center
Houston , Texas
NYU Langone Health
New York , New York
Advent Health
Orlando , Florida
University of California, San Diego
San Diego , California
Swedish Cancer Institute
Seattle , Washington
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
24.06.2024
Completion date
01.10.2027
Registry ID
NCT06307795
Source
clinicaltrials.gov
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