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Study of BTX-A51 for Advanced Solid Tumors and Breast Cancer

This study is testing BTX-A51, alone and with fulvestrant, for people with advanced solid tumors or metastatic breast cancer (mBC) that has not responded to standard treatments or for which no standard treatment is available. The study aims to find the safest and most effective dose of BTX-A51. Researchers will also look at how well BTX-A51 works. You may be able to join if you are 18 or older and have an advanced solid tumor. For some parts of the study, you would need to have ER+, HER2- mBC. The study is currently recruiting about 112 participants.

Study design
This is an open-label (meaning you and your doctors will know what treatment you are receiving), non-randomized study with about 112 participants. It is designed to find the right dose of BTX-A51.
What's involved
You would receive BTX-A51 for one 28-day cycle, with treatment up to 5 days per week. You may be offered continued access to BTX-A51 until your disease progresses or side effects become too severe.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from your first dose of BTX-A51 through 30 days after your last treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04872166

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Edgewood Oncology Inc.
~112 participants
Updated 2025-01-30 on ClinicalTrials.gov
What's tested:BTX-A51

At a glance

Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events after BTX-A51 administration alone and in combination with fulvestrant
Measured over 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)
+1 more outcome measured

Conditions

Advanced Solid Tumor
Metastatic Breast Cancer

Explore related trials

Breast CarcinomaSolid Neoplasm

Where it's being run

6 sites across 4 states
Florida2
Tennessee2
Ohio1
Texas1

Study leadership

  • Zung Thai, MD · STUDY_DIRECTOR · Edgewood Oncology Inc.

Who to contact

Zung Thai, MD
[email protected]
415-225-9338
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 last dose of study drug)
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)

Exclusion

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 compliance with study requirements
Pregnant, lactating, or breastfeeding.
Participation or plans to participate in another interventional clinical study.

What this trial measures

  • Incidence of adverse events after BTX-A51 administration alone and in combination with fulvestrantFrom 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)

    To examine the incidence of clinical and laboratory adverse events after multiple doses of BTX-A51 alone and in combination with fulvestrant.

  • Defining the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of BTX-A51alone and in combination with fulvestrantAt the end of Cycle 1 (each cycle is 28 days)

    To assess number of patients experiencing dose-limiting toxicities (DLTs)