Evaluating BTX-A51 for advanced solid tumors and breast cancer

An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, and Pharmacokinetics of BTX A51 Alone and in Combination With Fulvestrant in Subjects With Advanced Solid Tumors and Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer

This study is testing a new treatment called BTX-A51 for people with advanced solid tumors and metastatic breast cancer to see how safe it is and if it works better alone or with another medication.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Edgewood Oncology Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone
• Locations: 6 sites (Lake Mary, Florida and 5 other locations)
• Trial ID: NCT04872166 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label, nonrandomized Phase 1 trial aims to assess the safety, toxicity, pharmacokinetics, and preliminary efficacy of BTX-A51, both alone and in combination with fulvestrant, in patients with advanced solid tumors and metastatic breast cancer. The study will involve a dose escalation approach to determine the maximum tolerated dose and recommended Phase 2 dose, with participants receiving the treatment on a weekly schedule. The trial will consist of multiple phases, focusing on patients who have exhausted standard treatment options.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with incurable or metastatic solid tumors that are refractory to standard therapies.

Not a fit: Patients with tumors amenable to standard therapies or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors and metastatic breast cancer who have limited alternatives.

How similar studies have performed: While this approach is novel, similar studies evaluating new treatments for advanced solid tumors have shown promise in the past.

Eligibility criteria

Inclusion 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 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 Criteria:

* 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.

Where this trial is running

Lake Mary, Florida and 5 other locations

• Florida Cancer Specialists — Lake Mary, Florida, United States (Recruiting)
• Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
• The Linder Research Center at The Christ Hospital — Cincinnati, Ohio, United States (Completed)
• SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States (Completed)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Zung Thai, MD

Conditions Advanced Solid Tumor; Metastatic Breast Cancer