First-in-human imaging test with Ga-DWJ155 in advanced breast cancer and NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label phase I trial evaluating the safety, biodistribution, pharmacokinetics, and dosimetry of [68Ga]Ga-DWJ155 for radioligand imaging in adults with advanced breast cancer or advanced NSCLC adenocarcinoma. The study uses a single radiolabeled dose per participant and includes an imaging characterization phase followed by an expansion phase to better define imaging performance. Enrollment targets approximately 24–36 total participants across breast cancer and NSCLC cohorts. Imaging outcomes will be correlated with standard imaging and clinical data to inform future development of the radioligand. Safety monitoring and dose measurements are incorporated throughout the trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novartis Investigative Site
  Groningen, Provincie Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.