Testing BTX-9341 for advanced breast cancer
A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants With Advanced and/or Metastatic Breast Cancer
This study is testing a new drug called BTX-9341, alone and with another medication, to see if it can help people with advanced hormone receptor positive breast cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotheryx, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Rochester, Minnesota and 5 other locations) |
| Trial ID | NCT06515470 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of BTX-9341, both alone and in combination with fulvestrant, in patients with advanced or metastatic hormone receptor positive (HR+)/HER2 negative breast cancer. The study is structured in two parts: a dose escalation phase where participants receive increasing doses of BTX-9341, and a dose expansion phase where the selected dose is administered alongside fulvestrant. Participants will be treated in 28-day cycles, and the study aims to gather important data on how well the drug works and its safety profile.
Who should consider this trial
Good fit: Ideal candidates are individuals with metastatic and/or locally advanced HR+/HER2- breast cancer who have received limited prior chemotherapy and specific lines of endocrine therapy.
Not a fit: Patients with early-stage breast cancer or those who have not received prior endocrine therapy or chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer that is resistant to current therapies.
How similar studies have performed: While this is a first-in-human study, similar approaches in targeting HR+/HER2- breast cancer have shown promise in other trials, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Metastatic and/or locally advanced HR+/HER2- breast cancer (dose escalation: measurable disease and/or at least 1 lytic or mixed \[lytic + sclerotic\] bone lesion that can be assessed by CT or MRI or non-measurable disease \[including bone lesions\]; dose expansion: measurable disease) * Dose escalation: (a) received not more than 1 chemotherapy in the metastatic/advanced setting; (b) no limit to the lines of endocrine therapy (monotherapy or combination therapy) in the metastatic setting; (c) received CDK4/6 inhibitor therapy * Dose expansion: (a) received not more than 1 chemotherapy in metastatic/advanced setting; (b) received not more than 2 lines of endocrine therapy (monotherapy or combination therapy) and must have been on prior endocrine therapy for at least 6 months before progression; (c) received at most 2 lines of CDK4/6 inhibitor therapy (1 in the adjuvant setting and 1 in the metastatic setting) and must have been on prior CDK4/6 inhibitor therapy for at least 6 months * Acceptable hematologic function 1. ANC ≥ 1500 per mL. Note: Use of growth-factors to maintain the ANC criterion is prohibited. 2. Platelet count ≥ 100,000 per mL. Note: Use of transfusions or thrombopoietic agents to achieve the baseline platelet count criterion is prohibited. 3. Hemoglobin ≥ 9.0 g/dL. Note: Packed red blood cell transfusion is allowed up to 14 days prior to trial entry. * Acceptable liver function 1. Bilirubin ≤ 2.0 × institutional upper limit of normal (ULN) (or \< 3.0 × institutional ULN if Gilbert's disease is present) 2. Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 × institutional ULN (≤ 5.0 × institutional ULN if liver metastases present) 3. Alkaline phosphatase ≤ 2.5 × institutional ULN (≤ 5.0 × institutional ULN if bone or liver metastases present) * Able and willing to sign informed consent * Meets all study requirements in the opinion of the Investigator Exclusion Criteria: * RB1 (retinoblastoma) gene mutation * Symptomatic visceral disease * Clinical evidence or history of central nervous system metastasis * Abnormalities in coagulation, such as bleeding diathesis, or treatment with anticoagulants precluding injections of fulvestrant or luteinizing hormone-releasing hormone (LHRH) agonist
Where this trial is running
Rochester, Minnesota and 5 other locations
- Biotheryx Investigative Site — Rochester, Minnesota, United States (Recruiting)
- Biotheryx Investigative Site — Omaha, Nebraska, United States (Recruiting)
- Biotheryx Investigative Site — Houston, Texas, United States (Recruiting)
- Biotheryx Investigative Site — San Antonio, Texas, United States (Recruiting)
- Biotheryx Investigative Site — West Valley City, Utah, United States (Recruiting)
- Biotheryx Investigative Site — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Danette Powell
- Email: c-dpowell@biotheryx.com
- Phone: 858-354-1814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.