Phase 1 Breast Cancer Trial, Recruiting NCT07222267 Sponsor: BeOne Medicines Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Recruiting

NCT07222267
Recruiting Phase 1 🇦🇺 Australian site

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:

  • (Part 1A only) People with advanced or metastatic breast cancer or other solid tumours whose cancer has spread, and who have already tried all available standard treatments, cannot tolerate them, or have no standard treatments left.
  • (Parts 1B and 2A only) People with advanced breast cancer who have received between 1 and 3 prior rounds of systemic (whole-body) treatment for their metastatic disease, with no more than 2 of those rounds being chemotherapy (including certain antibody-based drug treatments).
  • (Parts 2B and 2C only) People with advanced breast cancer who are in a region where a specific class of drugs called CDK4/6 inhibitors are not approved or available as a first treatment, and who have never received CDK4/6 inhibitors or any prior systemic treatment for their advanced disease.
  • People with breast cancer whose diagnosis has been confirmed through laboratory testing of tissue or cell samples, following recognised medical guidelines.
  • Women with metastatic breast cancer who have been through menopause, or who are receiving treatment to suppress ovarian function.
  • People whose cancer can be measured on scans using a standard set of assessment criteria.
  • People who are in good general health, able to carry out everyday activities with little or no restriction (confirmed with trial site).
  • People whose liver, kidneys, and other organs are functioning adequately (confirm with trial site).

Who may not be able to join:

  • People who have previously been treated with a specific class of experimental drugs known as KAT6A/B or KAT7 inhibitors or degraders.
  • People who have active cancer spread to the membranes surrounding the brain or spinal cord, or who have brain metastases that are not being treated or are not stable.
  • People who have had a different cancer diagnosis within the past 3 years, with exceptions for the cancer being studied in this trial and for any localised cancer that has been successfully treated and is unlikely to need further treatment during the study period (confirm with trial site).

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 23 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: Study Director, BeOne Medicines

Phone: 877-828-5568

Australian sites

Blacktown Cancer and Haematology Centre, Blacktown, New South Wales
Chris Obrien Lifehouse, Camperdown, New South Wales
Cancer Research South Australia, Adelaide, South Australia
Austin Health, Heidelberg, Victoria
Peter Maccallum Cancer Centre, Melbourne, Victoria

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
BeOne Medicines
Registry
ClinicalTrials.gov
Start date
11 December 2025
Est. completion
30 September 2029

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇮🇹 Italy 🇪🇸 Spain 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1: Number of Participants with Adverse Events (AEs); Part 1: Recommended Dose for Expansion (RDFE); Part 2: Overall Response Rate (ORR)

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: 23 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