A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
Recruiting · NCT07117214 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
- ther protocol-defined inclusion/exclusion criteria may apply.
Where it is running
2 locations listed.
- Novartis Investigative Site - Groningen, Provincie Groningen, Netherlands
- Novartis Investigative Site - Groningen, Provincie Groningen, Netherlands