Phase 1 study
Recruiting Phase 1
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Westmead Hospital | Wentworthville | NSW | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
* Participants must be adults (≥18 years) and sign informed consent before undergoing any study-related procedures.
* Eligible participants must have advanced or metastatic solid tumors that are not treatable with surgery or radiation, and show evidence of MTAP gene homozygous deletion or MTAP protein loss based on tumor tissue analysis.
* Participants must have previously received standard treatment for their cancer type, and either experienced disease progression, be refractory, or be intolerant to such therapies.
* At least one measurable lesion is required, evaluated by standard imaging criteria (RECIST v1.1).
* Good general physical condition (ECOG performance status 0-1 for dose escalation; broader range allowed for other parts).
* Adequate function in key organs.
* Able to swallow oral medication and comply with study requirements.
* Women of childbearing potential and men with reproductive potential must use effective contraception during and after the study.
Exclusion Criteria:
* Recent cancer treatment, immunotherapy, or investigational drugs are not allowed before starting the study.
* Live vaccines received shortly before treatment are not allowed.
* Previous use of drugs with similar mechanisms to the study treatment is not allowed.
* Active or unstable brain or meningeal metastases, unless previously treated and stable without needing local treatment or high-dose steroids.
* History of other cancers within the last 2 years, unless low-risk and treated (e.g., in situ or certain skin cancers).
* Uncontrolled disease-related complications (e.g., abnormal calcium levels, fluid buildup around organs).
* Active HIV, hepatitis B or C infections that are not well-controlled.
* Ongoing serious infections or systemic conditions requiring isolation.
* Significant heart disease, such as recent heart failure, ischemia, or arrhythmias.
* History of severe digestive conditions or surgeries affecting drug absorption.
* Recent major surgery.
* Unresolved serious side effects from prior cancer treatment.
* Currently pregnant or breastfeeding.
* Poorly controlled blood pressure or lung conditions.
* Other serious illnesses (e.g., severe anemia, psychiatric or social issues affecting study compliance).
* Any condition that may pose a safety risk or interfere with the study, as judged by the investigator.
* Known drug or substance abuse that may affect study participation.
* Allergy to the study drug or any of its components.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 13 February 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.