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BTX-9341 + Fulvestrant for Breast Cancer

Phase 1
Recruiting
Research Sponsored by Biotheryx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic and/or locally advanced HR+/HER2- breast cancer with specific criteria for dose escalation and dose expansion
Acceptable liver function with specific criteria for Bilirubin, ALT/AST, and Alkaline phosphatase levels
Must not have
RB1 (retinoblastoma) gene mutation
Symptomatic visceral disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year from study start
Awards & highlights

Summary

This trial aims to test a new drug called BTX-9341 alone or in combination with fulvestrant in patients with advanced hormone receptor positive breast cancer. The study will first test different doses of

Who is the study for?
This trial is for individuals with advanced or metastatic HR+/HER2- breast cancer. Participants should have a type of breast cancer that has spread and responds to hormones but not the HER2 protein. They will test BTX-9341 alone or with fulvestrant, which is already used for this cancer.
What is being tested?
The study tests BTX-9341's safety and effectiveness, both on its own and combined with fulvestrant. It starts by giving small groups increasing doses of BTX-9341 (Part A), then moves to more people getting the best dose found plus fulvestrant (Part B).
What are the potential side effects?
Possible side effects include typical reactions to new cancer drugs like nausea, fatigue, allergic responses, potential liver issues from fulvestrant, and other unforeseen reactions related to BTX-9341.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer has spread and is HR+/HER2-.
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My liver function tests are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has a mutation in the RB1 gene.
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I have symptoms caused by cancer in my internal organs.
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My cancer has spread to my brain or spinal cord.
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I have bleeding issues or take blood thinners that prevent certain cancer treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year from study start
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year from study start for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: Determine MTD/MED of BTX-9341 in combination therapy
Part A: Determine MTD/MED of BTX-9341 in monotherapy
Part A: Number of Participants With Dose Limiting Toxicities (DLTs)
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: BTX-9341 + fulvestrant (Part B)Experimental Treatment2 Interventions
BTX-9341 capsule(s) administered orally QD in 28-day cycles and fulvestrant intermuscular injections on Day 15 and then once every 28 days
Group II: BTX-9341 + fulvestrant (Part A)Experimental Treatment2 Interventions
BTX-9341 capsule(s) administered orally QD in 28-day cycles and fulvestrant intermuscular injections on Day 15 and then once every 28 days
Group III: BTX-9341 (Part A)Experimental Treatment1 Intervention
BTX-9341 capsule(s) administered orally once daily (QD) in 28-day cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3890

Find a Location

Who is running the clinical trial?

Biotheryx, Inc.Lead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
Jeremy Barton, MDStudy DirectorChief Medical Officer
4 Previous Clinical Trials
153 Total Patients Enrolled
~55 spots leftby Sep 2027
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