A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors
Part of paid clinical trials in San Diego, California.
- Sponsor
- Avistone Biotechnology Co., Ltd.
- Study ID
- NCT06307795
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Locally Advanced or Metastatic Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ANS014004 — DRUGVarying doses of ANS014004
Study Details
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.
Key Dates
- Start date
- Jun 24, 2024
- Status verified
- Apr 2026
- Primary completion
- Apr 30, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 63 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ANS014004 MonotherapyPart 1 aims to determine the safety, tolerability, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of ANS014004. Part 2 aims to determine the safety, tolerability and evaluate anti-tumor activity of ANS014004 as monotherapy in select solid tumors.
Primary Outcome Measure
Incidence of Adverse Events (AEs) [ Time Frame: From the time of first dose to 28 days post last dose of ANS014004 ]
Central Contacts
- Avistone Clinical Study Information Center8610 84148921
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92093 | - |
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | - |
| Advent Health | Orlando | Florida | 32804 | - |
| Henry Ford Health Cancer | Detroit | Michigan | 48202 | - |
| NYU Langone Health | New York | New York | 10003 | - |
| The University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | - |
| NEXT Oncology, Virginia | Fairfax | Virginia | 22031 | - |
| Swedish Cancer Institute | Seattle | Washington | 98195 | - |
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