RecruitingPhase 1NCT07801508

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

A Phase I, Open Label Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors


Sponsor

Novartis Pharmaceuticals

Enrollment

66 participants

Start Date

Sep 22, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying [68Ga]Ga-DWJ155 for people with advanced breast cancer, advanced gastroesophageal adenocarcinoma, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST[68Ga]Ga-DWJ155

Radioligand imaging agent


Locations(1)

Novartis Investigative Site

Kyoto, Japan

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NCT07801508


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