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

NCT07801508 | Recruiting Phase 1

• 1 other identifier: CFKL480A02102
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Gastroesophageal adenocarcinoma (GEA); Gastric cancer (GC); Breast cancer (BC); Non-small cell lung cancer (NSCLC); Radioligand imaging (RLI); [68Ga]Ga-DWJ155; FKL480; Gallium; Adenocarcinoma; Positron emission tomography (PET); Dosimetry; HER2; Radiopharmaceutical

Outcome Measures

Primary Outcomes (2)

• Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions

  Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.

  Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155

• Standardized uptake value ratio (SUVr) of [68Ga]Ga-DWJ155 in tumor lesions relative to reference organs

  Standardized uptake value ratios (SUVr) will be calculated as the ratio of SUV in tumor lesions to SUV in normal organs.

  Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155

Secondary Outcomes (5)

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to 3 days after the administration of [68Ga]Ga-DWJ155

• Area under the concentration-time curve (AUC) of blood radioactivity (Imaging characterization part only)

  From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155

• Maximum observed concentration (Cmax) of blood radioactivity (Imaging characterization part only)

  From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155

• Absorbed radiation dose in selected organs and total body (Imaging characterization part only)

  Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155

• Effective radiation dose (Imaging characterization part only)

  Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155

Study Arms (1)

[68Ga]Ga-DWJ155

EXPERIMENTAL

Single administration of \[68Ga\]Ga-DWJ155

Diagnostic Test: [68Ga]Ga-DWJ155

Interventions

[68Ga]Ga-DWJ155 DIAGNOSTIC_TEST

Radioligand imaging agent

Also known as: FKL480

[68Ga]Ga-DWJ155

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Kyoto, 6068507, Japan

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Stomach Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+81337978748

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 3, 2026
• Study Start: September 8, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)