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Clinical Trials in Australia / NCT07801508
Recruiting Phase 1

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

NCT07801508 · tracked via the Priya Life Science Australia tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1
Started
2026-09-08
Last updated
2026-09-22

Condition(s) studied

Advanced Gastroesophageal AdenocarcinomaAdvanced Breast CancerTriple-negative Breast CancerAdvanced Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

[68Ga]Ga-DWJ155

[68Ga]Ga-DWJ155: Radioligand imaging agent

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: * Age ≥ 18 years old * Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients with one of the following indications: * 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 * 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+ * aGEA: regardless of any prior systemic line of therapy Key Exclusion Criteria: * Out-of-range laboratory values defined as: * Estimated glomerular filtration rate (eGFR; calculated using CKD-EPI 2021 formula, or measured) \< 40 mL/min/1.73m2 * Platelet count \< 75 x 10\^9/L * Hemoglobin \< 9 g/dL * Absolute neutrophil count (ANC) \< 1.0 x 10\^9/L * Patients with inadequate hepatic function * Urinary tract obstruction or urinary incontinence * Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcome measure(s)

  • Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions — Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
    Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.
  • Standardized uptake value ratio (SUVr) of [68Ga]Ga-DWJ155 in tumor lesions relative to reference organs — Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
    Standardized uptake value ratios (SUVr) will be calculated as the ratio of SUV in tumor lesions to SUV in normal organs.

Trial sites (1)

FacilityCityRegionStatus
Novartis Investigative Site Kyoto Japan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07801508 on ClinicalTrials.gov ↗ ← All trials in Australia