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

NCT06515470 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-06-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BTX-9341

Daily oral dose in 28-day cycles until maximum tolerated dose (MTD) or maximum evaluable dose (MED) determined

DRUG

Fulvestrant

500 mg intramuscular injections on Day 15 and then every 28 days

DRUG

BTX-9341

Daily oral dose in 28-day cycles using dose determined in Part A

Sponsors & Collaborators

  • Biotheryx, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeremy Barton, MD · Chief Medical Officer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2027-09-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515470 on ClinicalTrials.gov