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 |
|---|---|---|---|
| Novartis Investigative Site | Darlinghurst | 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:
* Male or female patients age ≥ 18 years.
* Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of care therapy, and are not considered appropriate for any standard therapy with proven benefit, in the investigator's judgment:
* Dose Escalation:
* Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting
* Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
* Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting
* Advanced NSCLC with AGAs who have received prior treatment
* Measurable disease as determined by RECIST version 1.1.
* Dose Expansion:
* Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting
* Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
* Advanced HR+/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
* Advanced HR-/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
* Advanced HR-/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
* Advanced NSCLC with AGAs, who have received prior treatment
* Advanced NSCLC without known AGAs who have received prior treatment.
* Advanced gastric/GEJ cancer with HER2 IHC 3+ or 2+ (ISH + or -), following disease progression after prior therapy in the advanced setting
* Advanced bladder cancer following disease progression after prior therapy in the advanced setting
* Measurable disease as determined by RECIST version 1.1.
Exclusion Criteria:
* Out-of-range laboratory values defined as:
* Creatinine clearance \< 60 mL/min (calculated using CKD-EPI 2021 formula, or measured)
* Total bilirubin \> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \>3.0 x ULN) or direct bilirubin \> 1.5 x ULN
* Alanine aminotransferase (ALT) \> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \> 5 x ULN
* Aspartate aminotransferase (AST) \> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \> 5 x ULN
* Lipase \> 1.5 x ULN
* Absolute neutrophil count (ANC) \< 1.5 x 109/L
* Hemoglobin \< 9 g/dL
* Platelet count \< 100 x 109/L
* Initiation of hematopoietic colony stimulating factors, thrombopoietin mimetics, or erythroid stimulating agents initiated ≤ 2 weeks prior to imaging agent administration.
* Use of transfusion support ≤4 weeks prior to imaging agent administration.
* Impaired cardiac function or clinically significant cardiac disease.
* Unmanageable urinary tract obstruction or urinary incontinence.
* Any serious uncontrolled infection (acute or chronic).
* Pregnant or breastfeeding women.
* Treatment with any of the following anti-cancer therapies prior to imaging agent administration within the stated timeframes:
* Prior treatment with any therapeutic radiopharmaceutical
* \< 10 half-lives for any imaging radiopharmaceutical
* ≤ 4 weeks for external beam radiation therapy (EBRT) or brachytherapy
* ≤ 6 months for lung-directed external beam radiotherapy
* Patients with non-tumor uptake of \[68Ga\]Ga-DWJ155 in tissues or organs that, in the opinion of the investigator, increases the risk associated with \[177Lu\]Lu-DWJ155 treatment.
Other protocol-defined inclusion/exclusion criteria may 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: 27 August 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.