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

RECRUITINGPhase 1Sponsored by Avistone Biotechnology Co., Ltd.
Actively Recruiting
PhasePhase 1
SponsorAvistone Biotechnology Co., Ltd.
Started2024-06-24
Est. completion2027-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →

NCT06307795

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerLocally Advanced or Metastatic Solid Tumors

Interventions1

ANS014004

Locations8 sites

University of California, San Diego
San Diego, California, 92093
Sarah Cannon Research Institute
Denver, Colorado, 80218
Advent Health
Orlando, Florida, 32804
Henry Ford Health Cancer
Detroit, Michigan, 48202
NYU Langone Health
New York, New York, 10003

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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