A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid
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.
| Condition(s) | Locally Advanced or Metastatic Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Avistone Biotechnology Co., Ltd. |
| Locations | San Diego, California, United States; Denver, Colorado, United States; Orlando, Florida, United States; Detroit, Michigan, United States; New York, New York, United States; Houston, Texas, United States (+9 more sites) |
| Start date | 2024-06-24 |
| NCT ID | NCT06307795 |
| Official listing | https://clinicaltrials.gov/study/NCT06307795 |