RECRUITING

Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced And/or Metastatic Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study includes a dose escalation part (Part A) where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 + fulvestrant followed by a dose expansion part (Part B) where participants will receive the dose of BTX-9341 selected in Part A + fulvestrant.

Official Title

A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants with Advanced And/or Metastatic Breast Cancer

Quick Facts

Study Start:2024-07-03

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06515470

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Danette Powell

CONTACT

858-354-1814

c-dpowell@biotheryx.com

Principal Investigator

Jeremy Barton, MD

STUDY_DIRECTOR

Chief Medical Officer

Study Locations (Sites)

Biotheryx Investigative Site

Omaha, Nebraska, 68130

United States

Biotheryx Investigative Site

Houston, Texas, 77030

United States

Biotheryx Investigative Site

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Biotheryx, Inc.

Jeremy Barton, MD, STUDY_DIRECTOR, Chief Medical Officer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-03

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-07-03

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

HR+/HER2-

Additional Relevant MeSH Terms

Breast Cancer