Actively Recruiting
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
Led by Novartis Pharmaceuticals · Updated on 2026-04-28
180
Participants Needed
7
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-DFC413 and safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with solid tumors
CONDITIONS
Official Title
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with one of these conditions: locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma, non-small cell lung cancer, HR+/HER2- ductal or lobular breast cancer, triple negative breast cancer, colorectal cancer, or soft tissue sarcoma (dose expansion only)
- Disease progression after or intolerance to standard therapies, unless ineligible to receive those therapies
- Patients with colorectal cancer having microsatellite instability-high or mismatch repair deficient status must also have disease progression or intolerance to immune checkpoint inhibitors unless ineligible
- Lesions must show uptake of 68Ga-NNS309 on imaging
You will not qualify if you...
- Absolute neutrophil count less than 1.5 x 10^9/L, hemoglobin less than 9 g/dL, or platelet count less than 100 x 10^9/L
- QT interval corrected by Fridericia's formula 470 msec or greater
- Estimated glomerular filtration rate less than 60 mL/min
- Unmanageable urinary tract obstruction or urinary incontinence
- Symptomatic central nervous system metastases or those requiring local CNS-directed therapy
- Previous radioligand therapy
- Radiation therapy within 4 weeks before first dose of [177Lu]Lu-DFC413
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
2
Novartis Investigative Site
Odense C, Denmark, 5000
Actively Recruiting
3
Novartis Investigative Site
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
4
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
5
Novartis Investigative Site
Haifa, Israel, 3109601
Actively Recruiting
6
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Actively Recruiting
7
Novartis Investigative Site
Singapore, Singapore, 168583
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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