Dysautonomia International

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

Purpose

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.

Condition

Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ANS03 monotherapy		Drug: ANS03 ANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).

Recruiting Locations

Memorial Sloan Kettering Cancer Center
New York, New York 10022

More Details

Status: Recruiting
Sponsor: Avistone Biotechnology Co., Ltd.

Study Contact

Avistone Clinical Study Information Center
8610 84148921
information.center@avistonebio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.