Actively Recruiting
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Led by Novartis Pharmaceuticals · Updated on 2026-04-24
162
Participants Needed
31
Research Sites
326 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-NNS309 and the safety and imaging properties of \[68Ga\]Ga-NNS309 in patients aged ≥ 18 years with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC) and colorectal cancer (CRC).
CONDITIONS
Official Title
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma with disease progression after or intolerance to cytotoxic chemotherapy, unless ineligible for such therapy
- Diagnosis of locally advanced unresectable or metastatic non-small cell lung cancer without actionable genomic alterations with progression after or intolerance to chemotherapy and immunotherapy, or with actionable genomic alterations with progression after or intolerance to targeted therapy, unless ineligible for such therapy
- Diagnosis of locally advanced unresectable or metastatic hormone receptor positive/HER2-negative ductal or lobular breast cancer with progression after or intolerance to at least 2 lines of therapy, unless ineligible for such therapy
- Diagnosis of locally advanced unresectable or metastatic triple negative breast cancer with progression after or intolerance to at least 2 lines of therapy, unless ineligible for such therapy
- (Dose escalation part only) Diagnosis of locally advanced or metastatic unresectable colorectal cancer with progression after or intolerance to cytotoxic chemotherapy, unless ineligible for such therapy
- For colorectal cancer patients with microsatellite instability-high or mismatch repair deficient status, progression after or intolerance to immune checkpoint inhibitor therapy unless ineligible
- Presence of lesions showing uptake on [68Ga]Ga-NNS309 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 (QTcF) 470 milliseconds or longer
- Creatinine clearance less than 60 mL/min
- Unmanageable urinary tract obstruction or urinary incontinence
- Radiation therapy within 4 weeks before the first dose of [177Lu]Lu-NNS309
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Uni of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
University of California LA
Los Angeles, California, United States, 90095
Actively Recruiting
3
Stanford University Medical Center
Palo Alto, California, United States, 94304
Actively Recruiting
4
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
7
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
8
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
9
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States, 77030
Actively Recruiting
10
University Of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
11
Novartis Investigative Site
Brussels, Belgium, 1000
Actively Recruiting
12
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
13
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2N2
Actively Recruiting
14
Novartis Investigative Site
Montreal, Quebec, Canada, H2W 1T8
Actively Recruiting
15
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
16
Novartis Investigative Site
Bron, France, 69677
Actively Recruiting
17
Novartis Investigative Site
Villejuif, France, 94800
Actively Recruiting
18
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
19
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
20
Novartis Investigative Site
München, Germany, 80377
Actively Recruiting
21
Novartis Investigative Site
Rostock, Germany, 18057
Actively Recruiting
22
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Actively Recruiting
23
Novartis Investigative Site
Milan, MI, Italy, 20133
Actively Recruiting
24
Novartis Investigative Site
Reggio Emilia, RE, Italy, 42123
Actively Recruiting
25
Novartis Investigative Site
Nijmegen, Gelderland, Netherlands, 6500HB
Actively Recruiting
26
Novartis Investigative Site
Utrecht, Netherlands, 3584 CX
Actively Recruiting
27
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
28
Novartis Investigative Site
Madrid, Spain, 28009
Actively Recruiting
29
Novartis Investigative Site
Madrid, Spain, 28040
Actively Recruiting
30
Novartis Investigative Site
Geneva, Switzerland, 1211
Actively Recruiting
31
Novartis Investigative Site
Lausanne, Switzerland, 1011
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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