A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
Recruiting now · Phase 1
Conditions studied: Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
In brief
This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of \[68Ga\]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative (HR+/HER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small Cell Lung Cancer (aNSCLC) adenocarcinoma.
Key facts
- Study ID
- NCT07117214
- Run by
- Novartis Pharmaceuticals
- People needed
- 36
- Starts
- 2026-06-26
- Expected to finish
- 2028-12-11
- Last updated by the study team
- 2026-07-07
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years old
- Patients with histologically or cytologically confirmed and documented HR+/HER2- advanced breast cancer (aBC), advanced defined as locoregionally advanced unresectable or metastatic, either untreated or currently receiving first line of systemic therapy OR patients with histologically or cytologically confirmed and documented HER2+ aBC, advanced defined as locoregionally advanced unresectable or metastatic, either untreated or relapsed/refractory (r/r) after one or more lines of treatment OR patients with histologically or cytologically confirmed and documented advanced NSCLC (aNSCLC) adenocarcinoma, advanced defined as locoregionally unresectable or metastatic, either untreated or currently receiving first line of systemic therapy.
- Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional CT scan.
You may not qualify if…
- Patients having out of range laboratory values for kidney function and blood markers as defined in the study protocol
- Patients with inadequate hepatic function
- Unmanageable urinary tract obstruction or urinary incontinence
- Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- Novartis Investigative Site — Groningen, Provincie Groningen, Netherlands (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.