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

Part of paid clinical trials in Lake Mary, Florida.

Sponsor
Edgewood Oncology Inc.
Study ID
NCT04872166
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BTX-A51 — DRUG
    One 28 day cycle of treatment will consist of 4 weeks of treatment with a weekly dosing schedule of up to 5 days per weekf.

Study Details

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 safety and tolerability of orally administered BTX-A51 at two dose levels combined with fulvestrant. The first combo cohort may be initiated after DEC review of the 6 subject lead-in phase of the high dose monotherapy cohort in Phase 1b. Dose escalation will proceed according to a 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).

Key Dates

Start date
Jun 7, 2021
Status verified
Jan 2025
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
112 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BTX-A51 Dose Cohort 1
    Starting dose (SD) of BTX-A51 administered orally 5 times per week in a 28-day cycle
  • Experimental: BTX-A51 Dose Cohort 2
    Up to 2-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
  • Experimental: BTX-A51 Dose Cohort 3
    Up to 3.5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
  • Experimental: BTX-A51 Dose Cohort 4
    Up to 5-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
  • Experimental: BTX-A51 Dose Cohort 5
    Up to 7-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
  • Experimental: BTX-A51 Dose Cohort 6
    Up to 10-times the SD of BTX-A51 administered orally 5 times per week in a 28-day cycle
  • Experimental: BTX-A51 in Combination with Fulvestrant Cohort 1
    Starting dose (SD) of BTX-A51 administered orally 3 times per week in a 28-day cycle; fulvestrant administered as a 500-mg intramuscular injection on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.
  • Experimental: BTX-A51 in Combination with Fulvestrant Cohort 2
    Up to 2-times the SD of BTX-A51 administered orally 3 times per week in a 28-day cycle; fulvestrant administered as a 500-mg intramuscular injection on days 1 and 15 of cycle 1 and on day 1 of subsequent 28-day cycles.

Primary Outcome Measure

Incidence of adverse events after BTX-A51 administration alone and in combination with fulvestrant [ Time Frame: From first dose of BTX-A51 through 30 days after the last BTX-A51 alone and in combination with fulvestrant treatment (subjects will be offered continued access to study BTX-A51 until disease progression or unacceptable toxicity) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsLake MaryFlorida32746
Alexander Philipovskiy, MD, PhD
Florida Cancer SpecialistsSarasotaFlorida34232
Judy Wang, MD
The Linder Research Center at The Christ HospitalCincinnatiOhio45219-
SCRI Oncology PartnersNashvilleTennessee37203
Denise A Yardley, MD
Tennessee Oncology, PLLCNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Senthil Damodaran, MD, PhD

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