A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pełnoletni wiek (18 lat i więcej)
- •Zdiagnozowany nieoperacyjny lub rozsiany nowotwór, który nie reaguje na standardowe leczenie lub brak dla niego standardowego leczenia
- •Możliwość zmierzenia guza w badaniach obrazowych
- •Prawidłowe funkcjonowanie organów wewnętrznych
- •Kobiety w wieku rozrodczym muszą nie być w ciąży i stosować skuteczną antykoncepcję (przez 3 miesiące po ostatniej dawce leku)
- •Mężczyźni aktywni seksualnie muszą stosować prezerwatywy (podczas i przez 3 miesiące po badaniu)
- •Zrozumienie badania i dobrowolne podpisanie dokumentu zgody
✗ Disqualifies
- •Spodziewana długość życia poniżej 3 miesięcy
- •Chemioterapia, hormonoterapia lub radioterapia w ciągu ostatnich 3 tygodni
- •Przewlekłe stosowanie kortyków powyżej 10 mg dziennie w ciągu ostatnich 4 tygodni
- •Poważna operacja lub uraz w ciągu ostatnich 4 tygodni
- •Zalegające skutki poprzedniego leczenia nowotworów (wyższego stopnia niż lekki)
- •Zaangażowanie mózgu nowotworami lub wcześniejsze poważne uszkodzenie mózgu spowodowane lekami
- •Poważne choroby serca, aktywne infekcje lub dodatni wynik testu na HIV/AIDS
- •Aktywne zapalenie wątroby (HCV/HBV) lub drugi nowotwór w przeszłości (bez remisji przez 3 lata)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- January 30, 2025
- Sex
- No restrictions
Therapies / drugs in trial
Locations (6)
Florida Cancer Specialists
Lake Mary, United States
Florida Cancer Specialists
Sarasota, United States
The Linder Research Center at The Christ Hospital
Cincinnati, United States
SCRI Oncology Partners
Nashville, United States
Tennessee Oncology, PLLC
Nashville, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Trial contact
Zung Thai, MD
Edgar Bautista, BS
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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