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 |
|---|---|---|---|
| Macquarie University | Sydney | NSW | Recruiting |
| Blacktown Hospital | Sydney | NSW | Recruiting |
| Sunshine Coast University Private Hospital | Birtinya | QLD | Recruiting |
| Tasman Oncology Research | Southport | QLD | Recruiting |
| Cancer Research SA | Adelaide | SA | Recruiting |
| Linear Clinical Research | Nedlands | WA | 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:
* Male and female participants ≥ 18 years of age
* Ph1a: Locally advanced or metastatic solid tumor relapsed or PD following local standard treatments, for which no standard treatment is available
* Ph1b: Eligible patients should have only received prior lines of systemic therapy according to SoC in the advanced/metastatic setting (not counting neoadjuvant/adjuvant treatment if completed \>6 months prior to recurrence)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Radiologically measurable disease by RECIST v1.1
* Mandatory adequate tumor tissue sample available
* Must have recovered from all clinically relevant toxicities from previous cancer therapies (to at least Grade 1, except for alopecia)
Exclusion Criteria:
* Known allergies/hypersensitivity/intolerance to or contraindication to exatecan, or any excipient
* Phase 1b: Prior antibody drug conjugate exposure with a topoisomerase 1 inhibitor payload
* Uncontrolled or significant cardiac disease including left ventricular ejection fraction (LVEF) \<50%, myocardial infarction or uncontrolled/unstable angina
* Has clinically active central nervous system (CNS) metastases
* Has a history of lung fibrosis or non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
* Active corneal disease, or history of corneal disease within 12 months prior to enrollment
* Other unacceptable abnormalities, medications or procedures as defined by protocol
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: 8 June 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.