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 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

Trial Details

NCT ID
NCT04872166
Phase
PHASE1
Sponsor
Edgewood Oncology Inc.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • BTX-A51
Locations (sample)
  • Lake Mary, Florida, United States|28.75888,-81.31784
  • Sarasota, Florida, United States|27.33643,-82.53065
  • Cincinnati, Ohio, United States|39.12711,-84.51439
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility Criteria

  • Demonstration of understanding and voluntarily signing of an informed consent form
  • Age ≥ 18 years
  • Histologically or cytologically documented, incurable or metastatic solid tumor that is refractory to or intolerant of all standard therapy or for …
  • Phase 1b and 1c only: Histologically confirmed diagnosis of ER+, HER2- mBC not amenable to resection or radiation therapy with curative intent.

For full eligibility, visit ClinicalTrials.gov.

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