NCT07117214

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

A Phase I, Open Label First in Human Study to Evaluate the Imaging Performance, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Advanced Breast Cancer and Advanced NSCLC

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a first-in-human (FIH), open-label, phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, PK and dosimetry properties in patients with aBC and aNSCLC adenocarcinoma. Approximately 15-21 aBC and 9-15 aNSCLC patients will be enrolled into the study. All patients enrolled in the study will receive a single administered radioactive dose of FKL480. The study will consist of an imaging characterization part and an expansion part.

Conditions

• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-DWJ155	Radioligand imaging agent

Timeline

• Start date: 2025-08-20
• Primary completion: 2027-01-26
• Completion: 2027-01-26
• First posted: 2025-08-12
• Last updated: 2025-08-12