Recruiting

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

The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of \[177Lu\]Lu-NNS309 and the safety, dosimetry 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).

ClinicalTrials.gov IDNCT06562192

PhasePHASE1

Enrollment162

SponsorNovartis Pharmaceuticals

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

Interventions

Drug: [68Ga]Ga-NNS309 — Radioligand imaging agent
Drug: [177Lu]Lu-NNS309 — Radioligand therapy

Primary outcomes

Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309 (From start of study treatment until 6 weeks or 4 weeks after, depending on dosing schedule)
Incidence and severity of adverse events and serious adverse events of [177Lu]Lu-NNS309 (From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months)
Dose modifications for [177Lu]Lu-NNS309 (From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks)
Dose intensity for [177Lu]Lu-NNS309 (From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks)

Eligibility information

Inclusion Criteria: * Age ≥ 18 years old * Patients with one of the following indications: * Locally advanced unresectable or metastatic PDAC with disease progression following, or intolerance to cytotoxic chemotherapy, 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 targeted therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular BC with disease progression following, or intolerance to, at least 2 lines of therapy, unless patient was ineligible to receive such therapy * Locally advanced unresectable or metastatic TNBC with disease progression following, or intolerance to, at least 2 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 * Patients must have lesions showing 68Ga-NNS309 uptake Exclusion Criteria: * Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L, hemoglobin \< 9 g/dL, or platelet count \< 100 x 10\^9/L * QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec * Calculated estimated glomerular filtration rate \< 60 mL/min/1.73m2 * Unmanageable urinary tract obstruction or urinary incontinence * Radiation therapy within 4 weeks prior to the first dose of \[177Lu\]Lu-NNS309 Other protocol-defined inclusion/exclusion criteria may apply.

Study locations

Uni of Alabama at Birmingham, Birmingham, Alabama 35249 United States
University of California LA, Los Angeles, California 90095 United States
Stanford University Medical Center, Palo Alto, California 94304 United States
Mayo Clinic Jacksonville, Jacksonville, Florida 32224 United States
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
BAMF Health, Grand Rapids, Michigan 49503 United States
Mayo Clinic Rochester, Rochester, Minnesota 55905 United States
Uni Of TX MD Anderson Cancer Cntr, Houston, Texas 77030 United States
University Of Washington, Seattle, Washington 98109 United States
Novartis Investigative Site, Brussels, 1000 Belgium

Showing 10 of 29 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.