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Trial Title:
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced And/or Metastatic Breast Cancer
NCT ID:
NCT06515470
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Fulvestrant
Conditions: Keywords:
HR+/HER2-
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BTX-9341
Description:
Daily oral dose in 28-day cycles until maximum tolerated dose (MTD) or maximum evaluable
dose (MED) determined
Arm group label:
BTX-9341 (Part A)
Arm group label:
BTX-9341 + fulvestrant (Part A)
Intervention type:
Drug
Intervention name:
Fulvestrant
Description:
500 mg intramuscular injections on Day 15 and then every 28 days
Arm group label:
BTX-9341 + fulvestrant (Part A)
Arm group label:
BTX-9341 + fulvestrant (Part B)
Other name:
Faslodex
Intervention type:
Drug
Intervention name:
BTX-9341
Description:
Daily oral dose in 28-day cycles using dose determined in Part A
Arm group label:
BTX-9341 + fulvestrant (Part B)
Summary:
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.
Detailed description:
This first-in-human (FIH), Phase 1 study of BTX-9341 is multicenter, nonrandomized, and
open-label to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary
efficacy of BTX-9341 in participants with advanced and/or metastatic HR+/HER2 breast
cancer. The study will include a dose escalation part (Part A) followed by a dose
expansion part (Part B). During Part A, BTX-9341 will initially be dose escalated alone
and then in combination with fulvestrant. A single combination therapy cohort of BTX-9341
+ fulvestrant will be further explored in Part B. BTX-9341 will be administered orally in
28-day treatment cycles.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Biotheryx Investigative Site
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Biotheryx Investigative Site
Facility:
Name:
Biotheryx Investigative Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Biotheryx Investigative Site
Facility:
Name:
Biotheryx Investigative Site
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Biotheryx Investigative Site
Start date:
July 3, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Biotheryx, Inc.
Agency class:
Industry
Source:
Biotheryx, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06515470
