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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07801508
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advanced Breast Cancer
  • Advanced Gastroesophageal Adenocarcinoma
  • Advanced Non-small Cell Lung Cancer
  • Triple-negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]Ga-DWJ155 — DIAGNOSTIC_TEST
    Radioligand imaging agent

Study Details

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.

Key Dates

First listed
Sep 3, 2026
Start date
Sep 22, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [68Ga]Ga-DWJ155
    Single administration of \[68Ga\]Ga-DWJ155

Primary Outcome Measure

Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions [ Time Frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155 ]

Central Contacts

  • Novartis Pharmaceuticals
    +41613241111
    [email protected]
  • Novartis Pharmaceuticals
    +81337978748

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