TheranosticTrials.org

Clinical Trial · NCT07660055

Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors

Overview

The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of \[177Lu\]Lu-DWJ155 and the safety and imaging properties of \[68Ga\]Ga-DWJ155 in patients with histologically or cytologically confirmed advanced HER2+, HR+/HER2-negative, or triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), HER2-3+ or 2+ (ISH positive or negative) gastric/gastroesophageal junction (GEJ) cancer, and bladder cancer.

Sponsor

Novartis

Phase

Phase 1

ClinicalTrials.gov

NCT07660055

Study contact

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682

Novartis Pharmaceuticals

+41613241111

Drug / Compound

DWJ155

Isotope(s):
Target(s):
  • HER2
Ligand Class: Small Molecules

DWJ155

Isotope(s):
Target(s):
  • HER2
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Advanced NSCLC with AGAs, who have received prior treatment
  • Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting
  • Measurable disease as determined by RECIST version 1.1.
  • Measurable disease as determined by RECIST version 1.1.
  • Advanced NSCLC without known AGAs who have received prior treatment.
  • Advanced HR+/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
  • Advanced HR-/HER2 0 breast cancer with disease progression after prior therapy in the advanced setting
  • Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
  • Advanced HR-/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
  • Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
  • Advanced NSCLC with AGAs who have received prior treatment
  • Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting

Exclusion

  • Impaired cardiac function or clinically significant cardiac disease.
  • Use of transfusion support ≤4 weeks prior to imaging agent administration.
  • ≤ 6 months for lung-directed external beam radiotherapy
  • ≤ 4 weeks for external beam radiation therapy (EBRT) or brachytherapy
  • Any serious uncontrolled infection (acute or chronic).
  • Platelet count \< 100 x 109/L
  • Hemoglobin \< 9 g/dL
  • Unmanageable urinary tract obstruction or urinary incontinence.
  • Prior treatment with any therapeutic radiopharmaceutical
  • Creatinine clearance \< 60 mL/min (calculated using CKD-EPI 2021 formula, or measured)
  • Absolute neutrophil count (ANC) \< 1.5 x 109/L
  • Pregnant or breastfeeding women.
  • Lipase \> 1.5 x ULN
  • Total bilirubin \> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \>3.0 x ULN) or direct bilirubin \> 1.5 x ULN