RecruitingPhase 1NCT07261631

Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors

A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and Safety and Imaging Properties of [68Ga]Ga-NNS309 in Patients With Solid Tumors


Sponsor

Novartis Pharmaceuticals

Enrollment

180 participants

Start Date

Nov 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I safety study testing a new radioactive drug called [177Lu]Lu-DFC413 in patients with certain advanced solid tumors, including pancreatic cancer (PDAC) and non-small cell lung cancer (NSCLC) that have not responded to prior treatments. **You may be eligible if...** - You are 18 or older - You have advanced, unresectable, or metastatic pancreatic cancer OR non-small cell lung cancer without actionable gene mutations - Your cancer has progressed after standard chemotherapy or immunotherapy, or you were unable to receive those treatments - You are in adequate physical health for the study procedures **You may NOT be eligible if...** - You have received certain prior radioactive treatments - Your kidney, liver, or bone marrow function is too poor - You have active brain metastases or uncontrolled infection 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

DRUG68Ga-NNS309

Diagnostic investigational radiopharmaceutical

DRUG177Lu-DFC413

Therapeutic investigational radiopharmaceutical


Locations(7)

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Odense C, Denmark

Novartis Investigative Site

Vandœuvre-lès-Nancy, France

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Tel Aviv, Israel

Novartis Investigative Site

Singapore, Singapore

View Full Details on ClinicalTrials.gov

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NCT07261631


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