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New treatment option for Advanced Solid Tumor
Official title A Study of BTX-A51 in People With Advanced Solid Tumor and Breast Cancer
ClinicalTrials.gov ID: NCT04872166
What this study is testing
What is BTX-A51?
BTX-A51 is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
You likely can't join if
- Life expectancy \<3 months, as determined by the Investigator.
- Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first...
- Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of BTX-A51
- Major trauma or major surgery within 4 weeks prior to first dose of BTX-A51.
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1 except for alopecia or Grade ≤2 immunotherapy-related thyroid...
- History of, or known, central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
See the full 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 which no standard therapy is available
- Phase 1b and 1c only: Histologically confirmed diagnosis of ER+, HER2- mBC not amenable to resection or radiation therapy with curative intent.
- Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
- Adequate organ function
- Females of childbearing age must not be pregnant at time of Screening/beginning of treatment and agree to either abstain from sexual intercourse or use highly effective methods of contraception (for up to 3 months after...
- Males sexually active with a woman of childbearing age must agree to use barrier method of birth control during and after the study (up to 3 months after last dose of study drug)
- Life expectancy \<3 months, as determined by the Investigator.
- Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 3 weeks prior to first dose of BTX-A51
- Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to first dose of BTX-A51
- Major trauma or major surgery within 4 weeks prior to first dose of BTX-A51.
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1 except for alopecia or Grade ≤2 immunotherapy-related thyroid toxicity.
- History of, or known, central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity.
- Clinically significant cardiac disease
- Active uncontrolled systemic fungal, bacterial, mycobacterial, or viral infection
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
- Active hepatitis C virus (HCV) or hepatitis B virus (HBV)
- Second primary malignancy that has not been in remission for greater than 3 years
- Any serious underlying medical (e.g., pulmonary, renal, hepatic, gastrointestinal, or neurological) or psychiatric condition (e.g., alcohol or drug abuse, dementia or altered mental status) or any issue that would limit...
- Pregnant, lactating, or breastfeeding.
- Participation or plans to participate in another treatment clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Lake Mary, Florida, United States
- Sarasota, Florida, United States
- Cincinnati, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lake Mary, Florida, United States; Sarasota, Florida, United States; Cincinnati, Ohio, United States; Nashville, Tennessee, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.