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NCT04872166 · ClinicalTrials.gov registry record · Phase 1

A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer

A Phase 1 study of Advanced Solid Tumor and Metastatic Breast Cancer, sponsored by Edgewood Oncology.

Recruiting
Registry status
Phase 1
Development phase
112
Enrollment target
6
Study locations

NCT04872166: Recruiting Phase 1 study of Advanced Solid Tumor and Metastatic Breast Cancer, sponsored by Edgewood Oncology.

NCT04872166 is a Phase 1 study of Advanced Solid Tumor and Metastatic Breast Cancer that is actively recruiting participants, run by Edgewood Oncology. The registered enrollment target is 112 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (42% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04872166, a Phase 1 study of Advanced Solid Tumor and Metastatic Breast Cancer, is actively recruiting participants, sponsored by Edgewood Oncology.

RECRUITING
Registry status
Phase 1
Development phase
112 participants
Enrollment target
6
Study locations

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

Primary Outcome

To examine the incidence of clinical and laboratory adverse events after multiple doses of BTX-A51 alone and in combination with fulvestrant.

Conditions Studied

Advanced Solid Tumor Metastatic Breast Cancer

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

FieldValue
Enrollment Target 112 participants
Start Date 2021-06-07
Est. Completion 2027-05
Phase Phase 1
Edgewood Oncology

2 total trials

What NCT04872166 shows while recruiting

NCT04872166 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (42% lower).

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.

NCT04872166 lists 6 locations in 4 states (Florida, Tennessee, Ohio).

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.

What interventions are being tested in trial NCT04872166?

The interventions under investigation include: BTX-A51 (DRUG).

Who is sponsoring clinical trial NCT04872166?

This trial is sponsored by Edgewood Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04872166's enrollment target sits among peer trials

112 108th of 189 higher than 82 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04872166

Source: ClinicalTrials.gov NCT04872166, the US trial registry maintained by the National Library of Medicine. NCT04872166 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.