Phase 2 Breast Cancer Trial, Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- Adults aged 18 or older, or teenagers aged 12–17 if a Safety Review Committee has given approval for that age group.
- People who have a solid tumour (cancer that forms a mass) that has spread locally or to other parts of the body, and whose tumour has a specific genetic change called a TP53 Y220C mutation.
- People whose general health and ability to carry out daily activities meets a standard score of 0 or 1 on a recognised medical scale (meaning fully active or restricted only in physically strenuous activity) (confirm with trial site).
- People who have already received at least one previous cancer treatment and whose cancer has continued to grow or spread since then.
- People whose organs (such as liver and kidneys) are functioning at an adequate level (confirm with trial site).
- For Phase 2 of the trial: people whose cancer can be measured on scans using standard criteria.
Additional criteria for the combination treatment part of the trial (Phase 1b):
- People who have either never received a type of immunotherapy called anti-PD-1 or anti-PD-L1 treatment, or whose cancer progressed while receiving it.
- People whose cancer can be measured on scans.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have received anti-cancer treatment within 21 days (or within 5 half-lives of that drug) before starting the study drug.
- People who have had radiotherapy within 14 days before starting the study drug.
- People whose cancer started in the brain or spinal cord (primary CNS tumour).
- People with a history of cancer spreading to the fluid around the brain or spinal cord, or who have had spinal cord compression.
- People with cancer that has spread to the brain, unless those brain metastases are neurologically stable and do not require steroid medication to manage symptoms.
- People who have had a stroke or a brief stroke-like episode (transient ischemic attack) within the 6 months before screening.
- People with certain heart conditions, including unstable chest pain (angina) within the past 6 months, uncontrolled high blood pressure, a heart attack within the past 6 months, heart failure, abnormal heart rhythm, or a prolonged electrical signal in the heart (QT interval prolongation).
- People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 inducers or strong CYP2C9 inhibitors or inducers) within 14 days before the first dose.
- People with a history of stomach or bowel conditions that could affect how the study drug is absorbed, or people who are unable to swallow oral medication.
- People who have previously had an organ transplant.
- People with another known active cancer, except for previously treated early-stage cervical cell changes or non-melanoma skin cancer.
- People with a known, active, and uncontrolled Hepatitis B, Hepatitis C, or HIV infection.
Additional exclusion for Phase 2 (single drug treatment):
- People whose cancer has a specific genetic change called a KRAS mutation (a single nucleotide variant).
Additional exclusions for Phase 1b (combination treatment):
- People who previously received certain immunotherapy treatments and had to stop because of a serious immune-related side effect (Grade 3 or higher).
- People who have received a live or live-attenuated vaccine within 30 days before the first dose.
- People with a diagnosis of immune system deficiency, or who have been taking ongoing steroid medication within 7 days before the first dose.
- People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.
- People with an active autoimmune disease that has required treatment with systemic medication within the past 2 years.
- People with a history of radiation-related lung inflammation (radiation pneumonitis).
- People with a history of, or currently active, non-infectious lung inflammation or scarring (pneumonitis or interstitial lung disease) that previously required steroid treatment.
- People with an active infection that requires systemic treatment.
- People with a known history of HIV infection.
- People who have previously received the study drug rezatapopt.
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.
Contact this trial
Principal Investigator: Marc Fellous, MD, Sr. Vice President of Medical Affairs
Phone: (609) 235-4038
Australian sites
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
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt; Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D); Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1); Phase 1b Combination Therapy (Part 1: Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt when administered in combination with pembrolizumab; Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the maximum tolerated dose (...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.