Actively Recruiting
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
Led by Edgewood Oncology Inc. · Updated on 2025-01-30
112
Participants Needed
6
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands and voluntarily signs informed consent
- Age 18 years or older
- Confirmed incurable or metastatic solid tumor refractory to or intolerant of standard therapy, or no standard therapy available
- For Phase 1b and 1c: confirmed estrogen receptor positive, HER2 negative metastatic breast cancer not suitable for surgery or radiation with curative intent
- Measurable disease per RECIST v1.1
- Adequate organ function
- Females of childbearing potential must not be pregnant and agree to abstain or use effective contraception during and for 3 months after treatment
- Males sexually active with females of childbearing potential must use barrier contraception during and for 3 months after treatment
You will not qualify if you...
- Life expectancy less than 3 months
- Treatment with antineoplastic therapy within 3 weeks prior to first dose
- Chronic corticosteroid use above 10 mg prednisone equivalent within 4 weeks prior to first dose
- Major trauma or surgery within 4 weeks prior to first dose
- Unresolved adverse events from prior cancer treatment above Grade 1, except alopecia or certain thyroid toxicities
- History or known central nervous system disease or severe CNS drug toxicity
- Significant heart disease
- Active uncontrolled fungal, bacterial, mycobacterial, or viral infection
- Positive test for HIV/AIDS
- Active hepatitis B or C infection
- Second primary cancer not in remission for over 3 years
- Serious medical or psychiatric conditions limiting study compliance
- Pregnant, lactating, or breastfeeding
- Current or planned participation in another interventional clinical study
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Trial Site Locations
Total: 6 locations
1
Florida Cancer Specialists
Lake Mary, Florida, United States, 32746
Actively Recruiting
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
3
The Linder Research Center at The Christ Hospital
Cincinnati, Ohio, United States, 45219
Completed
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Completed
6
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Z
Zung Thai, MD
CONTACT
E
Edgar Bautista, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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