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A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
NCT04872166 · View on ClinicalTrials.gov ↗
Study 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. 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 has been determined. Up to 40 additional subjects at each of the 2 dose levels will be enrolled to evaluate safety and preliminary efficacy of BTX-A51 in subjects with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), GATA3 mutant (mt) and wild-type (wt) metastatic breast cancer (mBC). Dosing in this phase of the study consists of the first cycle of therapy (i.e., 28 days). Phase 1c (Combination Safety Phase): The Phase 1c portion will evaluate the s
Conditions Studied
Interventions
- DRUG BTX-A51
Study Locations (6)
Florida
- Florida Cancer Specialists — Lake Mary
- Florida Cancer Specialists — Sarasota
Tennessee
- SCRI Oncology Partners — Nashville
- Tennessee Oncology, PLLC — Nashville
Ohio
- The Linder Research Center at The Christ Hospital — Cincinnati
Texas
- The University of Texas MD Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04872166
The ClinicalTrials.gov registry entry for NCT04872166 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edgewood Oncology, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention — of which BTX-A51 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04872166 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Florida, Tennessee, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04872166 about?
NCT04872166 is a clinical study titled "A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer". 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...
What is the current status of trial NCT04872166?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 112 participants. The study started on 2021-06-07. Estimated completion is 2027-05.
What conditions does trial NCT04872166 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Metastatic Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04872166?
The interventions under investigation include: BTX-A51 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04872166?
This trial is sponsored by Edgewood Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04872166 being conducted?
This trial has 6 study locations across Florida, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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