A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
NCT ID: NCT06307795
Last Updated: 2025-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
63 participants
INTERVENTIONAL
2024-06-24
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
ANS014004
Varying doses of ANS014004
Interventions
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ANS014004
Varying doses of ANS014004
Eligibility Criteria
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Inclusion Criteria
* 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
* Known active or untreated CNS metastases
* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
* Participants with serious cardiovascular or cerebrovascular diseases
18 Years
ALL
No
Sponsors
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Avistone Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Beijing Avistone Biotechnology Co., Ltd.
Locations
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Research Site
San Diego, California, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
Advent Health
Orlando, Florida, United States
Research Site
Detroit, Michigan, United States
Resarch Site
New York, New York, United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology, Virginia
Fairfax, Virginia, United States
Research Site
Seattle, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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ANS014004-I-US-01
Identifier Type: -
Identifier Source: org_study_id
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