A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- [68Ga]Ga-DWJ155
Treatment groups
36 Participants
are divided into 2 treatment groupsLocations
1Novartis Investigative Site9728, Groningen Netherlands
Sponsors and collaborators
Novartis Pharmaceuticals
Lead sponsor
Source ClinicalTrials.gov