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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT07117214

Registry updated: 2026-08-27
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Description

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.

Interventions

  • [68Ga]Ga-DWJ155 (Drug)
    Radioligand imaging agent

Eligibility criteria

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.

Conditions

Breast Neoplasms Carcinoma, Non-Small-Cell Lung

Locations

  • Novartis Investigative Site — Groningen, Provincie Groningen, Netherlands
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record