RecruitingPhase 1NCT06562192

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

Sponsor

Novartis Pharmaceuticals

Enrollment

162 participants

Start Date

Oct 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

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).

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new radioactive drug called [177Lu]Lu-NNS309 — which targets a protein found on certain cancer cells and delivers radiation directly to the tumor — in patients with advanced pancreatic, lung, breast, or colorectal cancer who have already tried other treatments. **You may be eligible if...** - You are 18 or older with advanced pancreatic cancer, non-small cell lung cancer, breast cancer (hormone receptor positive or triple-negative), or colorectal cancer - Your cancer has progressed on or you were unable to tolerate standard treatments - Your tumor shows uptake of the imaging agent [68Ga-NNS309] on a prior scan - Your blood counts and kidney function are adequate **You may NOT be eligible if...** - Your blood counts, kidney function, or heart rhythm are outside acceptable ranges - You have unmanageable urinary tract obstruction or severe urinary incontinence - You received radiation therapy within the last 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[68Ga]Ga-NNS309

Radioligand imaging agent

DRUG[177Lu]Lu-NNS309

Radioligand therapy

Locations(31)

Uni of Alabama at Birmingham

Birmingham, Alabama, United States

University of California LA

Los Angeles, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

BAMF Health

Grand Rapids, Michigan, United States

BAMF Health

Grand Rapids, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Uni Of TX MD Anderson Cancer Cntr

Houston, Texas, United States

University Of Washington

Seattle, Washington, United States

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Bron, France

Novartis Investigative Site

Villejuif, France

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

München, Germany

Novartis Investigative Site

Rostock, Germany

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Reggio Emilia, RE, Italy

Novartis Investigative Site

Nijmegen, Gelderland, Netherlands

Novartis Investigative Site

Utrecht, Netherlands

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Geneva, Switzerland

Novartis Investigative Site

Lausanne, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06562192

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