Condition: Advanced Solid Tumor · Metastatic Breast Cancer · Sponsor: Edgewood Oncology Inc.
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. BTX-A51 will be administered once daily on a weekly schedule of 5 days on/2 days off. Dose escalation will proceed according to a modified 3+3 design. Each cycle will consist of 28 days (4 weeks), and the DLT observation period will be the first cycle (i.e., 28 days after initiation of dosing). A DLT may be observed in no more than 0 out of 3 or 1 out of 6 subjects who have completed the DLT observation period before the next cohort initiates accrual. Barring DLT, sequential dose escalation of BTX-A51 is planned with up to a total of 6 dose levels; on the basis of these an MTD will be identified. The MTD is defined as the highest dose level with a subject incidence of DLTs of 0 or 1 out of 6 during the first 28 days of study drug dosing. A minimum of 6 subjects needs to be treated at a dose level before this dose level can be deemed as the MTD. Phase 1b (Monotherapy Dose Ranging Phase): Dose expansion may begin when the RP2D…
This description comes directly from the study's public registry record.
Zung Thai, MD · 415-225-9338 · zung@edgewoodonc.com
Edgar Bautista, BS · edgar@edgewoodonc.com
Always discuss trial participation with your own doctor first.
| Florida Cancer Specialists | Lake Mary, Florida, United States | Recruiting |
| Florida Cancer Specialists | Sarasota, Florida, United States | Recruiting |
| The Linder Research Center at The Christ Hospital | Cincinnati, Ohio, United States | Completed |
| SCRI Oncology Partners | Nashville, Tennessee, United States | Recruiting |
| Tennessee Oncology, PLLC | Nashville, Tennessee, United States | Completed |
| The University of Texas MD Anderson Cancer Center | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04872166