RecruitingPhase 1NCT06307795
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
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
Sponsor
Avistone Biotechnology Co., Ltd.
Enrollment
63 participants
Start Date
Jun 24, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- 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 Criteria4
- 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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Interventions
DRUGANS014004
Varying doses of ANS014004
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06307795
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