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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Biotheryx, Inc.
Study ID
NCT06515470
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BTX-9341 — DRUG
    Daily oral dose in 28-day cycles until maximum tolerated dose (MTD) or maximum evaluable dose (MED) determined
  • Fulvestrant — DRUG
    500 mg intramuscular injections on Day 15 and then every 28 days
  • BTX-9341 — DRUG
    Daily oral dose in 28-day cycles using dose determined in Part A

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Jun 2025
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
82 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BTX-9341 (Part A)
    BTX-9341 capsule(s) administered orally once daily (QD) in 28-day cycles
  • Experimental: BTX-9341 + fulvestrant (Part A)
    BTX-9341 capsule(s) administered orally QD in 28-day cycles and fulvestrant intermuscular injections on Day 15 and then once every 28 days
  • Experimental: BTX-9341 + fulvestrant (Part B)
    BTX-9341 capsule(s) administered orally QD in 28-day cycles and fulvestrant intermuscular injections on Day 15 and then once every 28 days

Primary Outcome Measure

Safety and Tolerability of BTX-9341 [ Time Frame: Up to 28 days after last dose of BTX-9341 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Biotheryx Investigative SiteRochesterMinnesota55905
Biotheryx Investigative Site
Biotheryx Investigative SiteOmahaNebraska68130
Biotheryx Investigative Site
Biotheryx Investigative SiteHoustonTexas77030
Biotheryx Investigative Site
Biotheryx Investigative SiteSan AntonioTexas78229
Biotheryx Investigative Site
Biotheryx Investigative SiteWest Valley CityUtah84119
Biotheryx Investigative Site
Biotheryx Investigative SiteFairfaxVirginia22031
Biotheryx Investigative Site

Find similar trials in Rochester, MN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Biotheryx Investigative Site· Rochester, MNBiotheryx Investigative Site· Omaha, NEBiotheryx Investigative Site· Houston, TXBiotheryx Investigative Site· San Antonio, TXBiotheryx Investigative Site· West Valley City, UTBiotheryx Investigative Site· Fairfax, VA

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