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RecruitingPhase 1NCT06307795

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

Trial Parameters

ConditionLocally Advanced or Metastatic Solid Tumors
SponsorAvistone Biotechnology Co., Ltd.
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment63
SexALL
Min Age18 Years
Max AgeN/A
Start Date2024-06-24
Completion2027-04
Interventions
ANS014004

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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.

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

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