A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors
Part of paid clinical trials in New York, New York.
- Sponsor
- Avistone Biotechnology Co., Ltd.
- Study ID
- NCT06716138
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ANS03 — DRUGANS03 is a rationally next generation TKI targeting both ROS1 and NTRK developed by Shenzhen Avistone Biotechnology (the sponsor).
Study Details
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.
Key Dates
- Start date
- Mar 6, 2025
- Status verified
- Mar 2026
- Primary completion
- Dec 30, 2027
- Completion
- Mar 30, 2029
Study Design
- Enrollment
- 96 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ANS03 monotherapy
Primary Outcome Measure
Incidence of Adverse Events (AEs) [ Time Frame: From the time of first dose to 28 days post last dose of ANS03 ]
Central Contacts
- Avistone Clinical Study Information Center8610 84148921
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10022 | - |
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