TheranosticTrials.org

Clinical Trial · NCT07117214

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

Overview

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.

Sponsor

Novartis

Phase

Phase 1

Contacts

Novartis Pharmaceuticals (CONTACT)

Novartis Pharmaceuticals (CONTACT)

novartis.email@novartis.com

+41613241111

ClinicalTrials.gov

NCT07117214

Drug / Compound

DWJ155

Isotope(s):
Target(s):
  • HER2

Eligibility

Inclusion

  • Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional CT scan.
  • 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.

Exclusion

  • Unmanageable urinary tract obstruction or urinary incontinenceOther protocol-defined inclusion/exclusion criteria may apply.
  • Patients having out of range laboratory values for kidney function and blood markers as defined in the study protocol
  • Patients with inadequate hepatic function