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

Launched by NOVARTIS PHARMACEUTICALS · Aug 11, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new imaging agent called [68Ga]Ga-DWJ155 to see how well it works and how safe it is for use in adults with certain types of advanced breast cancer or advanced non-small cell lung cancer. The main goal is to understand how this agent behaves in the body and how clearly it can show cancer during imaging scans.

People who may be eligible to join are adults 18 years or older who have advanced breast cancer that is either hormone receptor positive and HER2 negative, or HER2 positive, as well as those with advanced non-small cell lung cancer of a specific type called adenocarcinoma. Eligible participants must have measurable cancer that can be seen on a standard CT scan and may be either newly diagnosed or currently receiving treatment. Before joining, patients will be checked to ensure their kidney and liver function are within safe limits. Participants can expect to undergo imaging tests using this new agent, which will help doctors learn more about its safety and effectiveness in detecting cancer. This study is in the early phase, meaning it is the first time this imaging agent is being tested in humans.

Gender

ALL

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.