Phase 1 Breast Cancer Trial, Recruiting NCT06515470 Sponsor: Biotheryx, Inc. Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Recruiting

NCT06515470
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People diagnosed with breast cancer that is hormone receptor positive (HR+) and HER2 negative (HER2-), and has spread to other parts of the body or nearby tissues (confirm with trial site for specific disease measurement requirements depending on which part of the trial applies).
  • People in the dose escalation part who have received no more than one chemotherapy treatment for advanced or metastatic disease, have previously been treated with a type of targeted therapy called a CDK4/6 inhibitor, and have had any number of hormone therapy treatments.
  • People in the dose expansion part who have received no more than one chemotherapy treatment for advanced or metastatic disease, no more than two lines of hormone therapy (with at least six months on that therapy before the cancer progressed), and no more than two courses of CDK4/6 inhibitor therapy (with at least six months on that therapy).
  • People whose blood counts are within acceptable ranges, including white blood cell levels, platelet counts, and haemoglobin levels, without needing growth factors or transfusions to reach those levels (a red blood cell transfusion is allowed if it was given at least 14 days before joining the trial).
  • People whose liver function test results are within acceptable ranges as determined by the trial site.
  • People who are willing and able to give informed consent to participate.
  • People who meet all study requirements in the opinion of the treating investigator.

Who may not be able to join:

  • People who have a mutation in the RB1 (retinoblastoma) gene.
  • People whose cancer has spread to internal organs and is causing noticeable symptoms.
  • People who have a history of, or current signs of, cancer that has spread to the brain or central nervous system.
  • People who have blood clotting problems or who are taking blood-thinning medications that would make injections of certain study medications (fulvestrant or LHRH agonist) unsafe.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Jeremy Barton, MD, Chief Medical Officer

Phone: 858-354-1814

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Biotheryx, Inc.
Registry
ClinicalTrials.gov
Start date
3 July 2024
Est. completion
30 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and Tolerability of BTX-9341; Part A: Number of Participants With Dose Limiting Toxicities (DLTs); Part A: Determine MTD/MED of BTX-9341 in monotherapy; Part A: Determine MTD/MED of BTX-9341 in combination therapy; Part B Combination Therapy: Objective Response (OR) rate

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov