Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
NCT07660055 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2026-07-28
Summary
The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of \[177Lu\]Lu-DWJ155 and the safety and imaging properties of \[68Ga\]Ga-DWJ155 in patients with histologically or cytologically confirmed advanced HER2+, HR+/HER2-negative, or triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), HER2-3+ or 2+ (ISH positive or negative) gastric/gastroesophageal junction (GEJ) cancer, and bladder cancer.
Conditions
- Breast Cancer
- Non-small Cell Lung Cancer (NSCLC)
- Gastric/Gastroesophageal Junction (GEJ) Cancer
- Bladder Cancer
Interventions
- DIAGNOSTIC_TEST
-
[68Ga]Ga-DWJ155
Radioligand imaging agent
- DRUG
-
[177Lu]Lu-DWJ155
Radioligand therapy
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-16
- Primary Completion
- 2032-05-24
- Completion
- 2032-05-24
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- Japan
Study Locations
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