Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
NCT06562192 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 162
Last updated 2026-04-24
Summary
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
- Pancreatic Ductal Adenocarcinoma
- Non-small Cell Lung Cancer
- HR+/HER2- Ductal and Lobular Breast Cancer
- Triple Negative Breast Cancer
- Colorectal Cancer
Interventions
- DRUG
-
[68Ga]Ga-NNS309
Radioligand imaging agent
- DRUG
-
[177Lu]Lu-NNS309
Radioligand therapy
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-15
- Primary Completion
- 2031-01-15
- Completion
- 2031-01-16
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Canada
- France
- Germany
- Israel
- Italy
- Netherlands
- Spain
- Switzerland
Study Locations
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