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A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers

RecruitingPhase 1Ages 18 Years - 100 YearsAllNovartis Pharmaceuticals
NCT07117214 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 Other protocol-defined inclusion/exclusion criteria may apply.
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What it tests

  • [68Ga]Ga-DWJ155
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Where

1 site
Novartis Investigative Site
Groningen, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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