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A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

RECRUITINGPhase 1Sponsored by Avistone Biotechnology Co., Ltd.
Actively Recruiting
PhasePhase 1
SponsorAvistone Biotechnology Co., Ltd.
Started2025-03-06
Est. completion2027-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06716138

Summary

This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
* Life expectancy ≥ 12 weeks
* Measurable disease per RECIST v1.1
* Adequate organ and marrow function as defined in the protocol
* With documentation of ROS1 or NTRK alteration

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 Harboring a ROS1 or NTRK Alteration

Locations1 site

Research Site
New York, New York, 10022

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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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