TheranosticTrials.org

Clinical Trial · NCT07801508

A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors

Overview

The purpose of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics (PK) of \[68Ga\]Ga-DWJ155, also known as FKL480, in patients ≥ 18 years of age with advanced gastroesophageal adenocarcinoma (aGEA, where GEA is defined as adenocarcinomas of the distal esophagus, the gastroesophageal junction, and the stomach), hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) advanced breast cancer (aBC), HER2 positive (HER2+) aBC, triple-negative breast cancer (TNBC) and advanced non-small cell lung cancer (aNSCLC) adenocarcinoma.

Sponsor

Novartis

Phase

Phase 1

Contacts

Novartis Pharmaceuticals (CONTACT)

+81337978748

Novartis Pharmaceuticals (CONTACT)

novartis.email@novartis.com

+41613241111

ClinicalTrials.gov

NCT07801508

Drug / Compound

DWJ155

Isotope(s):
Target(s):
  • HER2

Eligibility

Inclusion

  • Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  • aNSCLC adenocarcinoma: Prior to, during or having completed their first line of systemic therapy. If HER2 immunohistochemistry (IHC) will be routinely performed and available, then HER2 ≥1+
  • HR+/HER2- aBC and TNBC: untreated or currently receiving or having completed first line of systemic therapy (preferred); HER2+ aBC: regardless of any prior systemic therapy
  • Patients with one of the following indications:
  • aGEA: regardless of any prior systemic line of therapyKey
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion

  • Absolute neutrophil count (ANC) \< 1.0 x 10\^9/L
  • Hemoglobin \< 9 g/dL
  • Out-of-range laboratory values defined as:
  • Patients with inadequate hepatic function
  • Platelet count \< 75 x 10\^9/L
  • Estimated glomerular filtration rate (eGFR; calculated using CKD-EPI 2021 formula, or measured) \< 40 mL/min/1.73m2