OncoMatch/Clinical Trials/NCT07801508
A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
Official title: 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
Is NCT07801508 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies non-drug interventions for advanced gastroesophageal adenocarcinoma.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Breast Carcinoma
Triple-Negative Breast Cancer
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) expression (≥1+)
If HER2 immunohistochemistry (IHC) will be routinely performed and available, then HER2 ≥1+
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Lab requirements
Blood counts
Platelet count < 75 x 10^9/L; Hemoglobin < 9 g/dL; ANC < 1.0 x 10^9/L
Kidney function
eGFR < 40 mL/min/1.73m2 (CKD-EPI 2021 or measured)
Liver function
Patients with inadequate hepatic function [excluded]
Out-of-range laboratory values defined as: eGFR < 40 mL/min/1.73m2; Platelet count < 75 x 10^9/L; Hemoglobin < 9 g/dL; ANC < 1.0 x 10^9/L. Patients with inadequate hepatic function [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07801508 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ERBB2?
Yes, ERBB2 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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