A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants with Advanced and/or Metastatic Breast Cancer
Primary Objectives:
Part A (Dose Escalation) - To evaluate the safety and tolerability of BTX-9341 monotherapy and/or combination therapy with fulvestrant and determine the MTD/MED of BTX-9341.
Part B (Dose Expansion) - To obtain preliminary evidence of BTX-9341 efficacy and establish the RP2D of BTX-9341 when administered in combination with fulvestrant
Secondary Objectives:
Parts A and B (Dose Escalation and Dose Expansion
- To characterize the plasma PK profile of R and S isomers following single and multiple doses of BTX-9341 administered as a single agent and/or in combination with fulvestrant
- To determine the interconversion rate between the R and S isomers (both active isomers) of BTX-9341
- To determine the efficacy of BTX-9341 administered as a single agent and/or in combination with fulvestrant
Part B Only (Dose Expansion)
- To further assess the safety and tolerability of BTX-9341 administered in combination with fulvestrant
- Rutgers University
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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