Phase 2 study
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Macquarie University | Macquarie Park | NSW | Recruiting |
| GenesisCare North Shore | St Leonards | NSW | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | QLD | Recruiting |
| Cancer Research South Australia | Adelaide | SA | Recruiting |
| St John of God Subiaco Hospital | Subiaco | WA | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 15 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:
* Patients aged ≥18 years
* Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)
* Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours
* Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options
* Availability of archival tumour tissue sample to confirm HER2 status
* Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further inclusion criteria apply.
Exclusion criteria:
* Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer or metastatic gastroesophageal adenocarcinoma
* Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC)
* Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs)
* Previous or concomitant malignancies other than the one treated in this trial within the previous 3 years except the following effectively treated cancers: nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, localized prostate cancer on watchful waiting or active surveillance, and other effectively treated malignancies that are considered cured by local treatment
* Uncontrolled or symptomatic brain or subdural metastases during screening
* Known diagnosis of leptomeningeal disease
* Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther exclusion criteria apply.
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 October 2026.
- This page last checked by Voxsanity: 15 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.