NCT06562192

Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a \[68Ga\]Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for \[177Lu\]Lu-NNS309 treatment. In the escalation part, different doses of \[177Lu\]Lu-NNS309 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of \[177Lu\]Lu-NNS309 at the RD(s) determined during the escalation part. The end of study will occur when all patients per disease group in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Non-small Cell Lung Cancer
• HR+/HER2- Ductal and Lobular Breast Cancer
• Triple Negative Breast Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-NNS309	Radioligand imaging agent
DRUG	[177Lu]Lu-NNS309	Radioligand therapy

Timeline

• Start date: 2024-10-15
• Primary completion: 2031-01-15
• Completion: 2031-01-16
• First posted: 2024-08-20
• Last updated: 2026-04-08

Locations

31 sites across 10 countries: United States, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland

Regulatory

• FDA-regulated drug study