Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
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
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 9, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: 68Ga-NNS309; Drug: 177Lu-DFC413
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Adults ≥ 18 years with one of the following indications:
- Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, unless patient was ineligible to receive such therapy
- Locally advanced unresectable or metastatic NSCLC without any actionable genomic alterations with disease progression following, or intolerance to chemotherapy and immunotherapy, unless patient was ineligible to receive such therapy, or locally advanced unresectable or metastatic NSCLC with an actionable genomic alteration with disease progression following, or intolerance to chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy
- Locally advanced unresectable or metastatic HR+/HER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy, unless patient was ineligible to receive such therapy
- Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two lines of therapy, unless patient was ineligible to receive such therapy
- Locally advanced or metastatic unresectable CRC with disease progression following, or intolerance to cytotoxic chemotherapy, unless patient was ineligible to receive such therapy. Patients with known microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status must also have had disease progression following, or intolerance to, immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
- (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy
- Patients must have lesions showing 68Ga-NNS309 uptake
- Absolute neutrophil count (ANC) \< 1.5 x 109/L, hemoglobin \< 9 g/dL, or platelet count \< 100 x 109/L
- QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
- eGFR \< 60 mL/min/1.73m2, calculated using CKD-EPI 2021 or measured
- Unmanageable urinary tract obstruction or urinary incontinence
- Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy
- Any prior radioligand therapy
- Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-DFC413 Other protocol-defined inclusion/
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- United TheranosticsPrinceton, New Jersey
- Novartis Investigative SiteMontreal, Quebec
- Novartis Investigative SiteOdense C
- Novartis Investigative SiteVandœuvre-lès-Nancy
- Novartis Investigative SiteEssen
- Novartis Investigative SiteHaifa
- Novartis Investigative SiteTel Aviv
- Novartis Investigative SiteSingapore
- Novartis Investigative SiteSingapore
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 9, 2026. Always confirm current availability with the study team.