RecruitingBreast CancerNon-small Cell Lung Cancer (NSCLC)Gastric/Gastroesophageal Junction (GEJ) Cancer
Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Novartis Pharmaceuticals
You may qualify if…
- ✓ Male or female patients age ≥ 18 years.
- ✓ Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of care therapy, and are not considered appropriate for any standard therapy with proven benefit, in the investigator's judgment:
- ✓ Dose Escalation:
- ✓ Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting
- ✓ Advanced HR+/HER2-low breast cancer with disease progression after prior therapy in the advanced setting
- ✓ Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting
- ✓ Advanced NSCLC with AGAs who have received prior treatment
- ✓ Measurable disease as determined by RECIST version 1.1.
You may not qualify if…
- ✕ Out-of-range laboratory values defined as:
- ✕ Creatinine clearance \< 60 mL/min (calculated using CKD-EPI 2021 formula, or measured)
- ✕ Total bilirubin \> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \>3.0 x ULN) or direct bilirubin \> 1.5 x ULN
- ✕ Alanine aminotransferase (ALT) \> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \> 5 x ULN
- ✕ Aspartate aminotransferase (AST) \> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \> 5 x ULN
- ✕ Lipase \> 1.5 x ULN
- ✕ Absolute neutrophil count (ANC) \< 1.5 x 109/L
- ✕ Hemoglobin \< 9 g/dL
Where it's recruiting
Nebraska
Omaha
Source: ClinicalTrials.gov · NCT07660055 · last updated 2026-08-27