Printed from Voxsanity (voxsanity.com.au) — NCT05111561 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Breast Cancer Trial, Recruiting
NCT05111561
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
- People who have been diagnosed with an advanced, metastatic, or inoperable solid tumour that has stopped responding to standard treatment or has come back after standard treatment.
- People who have triple negative breast cancer (a specific type of breast cancer defined by low levels of certain receptors), OR people who have a solid tumour with specific genetic changes affecting a pathway called RAS signalling (including changes in genes called KRAS, NRAS, HRAS, BRAF, or NF1) — identified through a type of genetic test called next generation sequencing (NGS).
- For the first part of the trial, people whose cancer can be detected on scans (measurable or evaluable). For the second part, the cancer must be clearly measurable on scans according to a standard set of guidelines.
- People who have waited at least 4 weeks since their last chemotherapy (or 6 weeks for certain specific chemotherapy drugs), radiation therapy, or other cancer treatments, or at least 5 half-lives since certain targeted or hormonal treatments — whichever comes sooner.
- People aged 18 or older (children are not included because there is no safety data available for this age group).
- People who are well enough to carry out some daily activities, based on a standard doctor-assessed scale (confirm with trial site).
- People whose blood test results meet certain minimum levels for white blood cells, platelets, and haemoglobin (red blood cells).
- People whose liver function blood tests fall within an acceptable range, with a slightly higher allowance for people with a known condition called Gilbert's syndrome.
- People whose kidneys are working well enough, based on a calculated measure of kidney function.
- People whose blood clotting test results are within an acceptable range.
- People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
- People with a history of hepatitis B who have an undetectable viral load while on appropriate treatment.
- People who had hepatitis C and have been successfully treated and cured, or who are currently being treated for hepatitis C and have an undetectable viral load.
- People who previously had cancer spread to the brain, if that spread was treated, has not grown on follow-up scans for at least 4 weeks, symptoms have returned to baseline, and steroids have not been needed for at least 7 days before starting the trial. This does not apply to cancer in the lining of the brain or primary brain cancers.
- People who have had or currently have another separate cancer, as long as that cancer or its treatment is unlikely to interfere with this trial's results.
- People whose heart function meets a certain standard based on a heart classification system (confirm with trial site).
- People whose heart rhythm measurement (a reading called QTcF) is below a certain level on an ECG.
- People who are able to use reliable contraception during the trial and for 4 months after finishing treatment. This applies to both women who could become pregnant and men. The effects of the trial drugs on an unborn baby are unknown and the drugs are considered potentially harmful to a developing foetus.
- People who are able to understand and sign a consent form, including those who have an authorised representative available to assist with decision-making.
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 still have side effects from previous cancer treatment that are worse than mild (above Grade 1), with the exception of hair loss, certain nerve-related symptoms, or hormone conditions managed with replacement therapy.
- People who are currently taking part in another clinical trial involving an experimental treatment.
- Breast cancer patients who have a history of having hormone receptor-positive breast cancer.
- People whose tumour has certain genetic changes in a pathway called PI3K (including changes in genes such as PTEN, PIK3R1, PIK3CA, Akt, or mTOR).
- People who have previously been treated with a type of drug known as a BET, RAF, MEK, or ERK inhibitor.
- People who have had a serious allergic reaction to drugs with a similar make-up to the two trial drugs (ZEN-3694 and binimetinib).
- People who need full therapeutic doses of blood-thinning medication (low-dose preventative blood thinners may be allowed — confirm with trial site). Also, people currently taking certain medications that strongly affect how the body processes a specific liver enzyme (called CYP3A4), which must be stopped at least 7 days before starting the trial.
- People with other serious illnesses that are not well controlled.
- People with a mental health condition or personal circumstances that would make it difficult to follow the trial requirements.
- People who are pregnant or breastfeeding, as the trial drugs carry a risk of harm to an unborn baby or infant.
- People who have had a stroke, heart attack, or unstable chest pain within the 6 months before starting the trial.
- People who have a medical condition that is likely to affect how well the body absorbs tablets or oral medication (such as having had part of the stomach removed, certain bowel conditions, ongoing diarrhoea, or delayed stomach emptying).
- People who have a history of a specific eye condition called retinal vein occlusion.
- People who have a history of inflammation of the lungs (pneumonitis) or scarring of the lung tissue (interstitial lung disease).
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.
GP referral letter
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Trial details
Status
Recruiting
Phase
Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
2 August 2022
Est. completion
14 March 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Incidence of dose limiting toxicities (Part 1 [Dose Escalation]); Incidence of AEs (Part 2 [Dose Expansion])
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 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.