A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
NCT04872166
This study is recruiting at 4 US sites in 3 states, according to its ClinicalTrials.gov record last updated .
Summary
This is a multicenter, open label, nonrandomized, sequential dose escalation/dose ranging, multiple dose study designed to evaluate the safety, toxicity, and PK as well as preliminary efficacy of BTX-A51 alone and in combination with fulvestrant in subjects with advanced solid tumors. The study will be done in three phases, described below. Phase 1a (Dose Escalation Phase): The Phase 1a portion is designed to determine the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of orally administered BTX-A51.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Advanced Solid Tumor
- Metastatic Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Edgewood Oncology Inc.
- Last updated on ClinicalTrials.gov
- January 30, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Florida · 2
- Florida Cancer Specialists · Lake Mary, FL
- Florida Cancer Specialists · Sarasota, FL
Tennessee · 1
- SCRI Oncology Partners · Nashville, TN
Texas · 1
- The University of Texas MD Anderson Cancer Center · Houston, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.