A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
Phase 1 – testing safety in a small group of people
Conditions:
Locally Advanced or Metastatic Solid Tumors
Sponsor: Avistone Biotechnology Co., Ltd.
trial.available_in:
БГ
Overview
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.
Who can participate
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