Recruiting
Phase 1

[177Lu]Lu-NNS309

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06562192

Conditions

Pancreatic Ductal Adenocarcinoma

Non-small Cell Lung Cancer

HR+/HER2- Ductal and Lobular Breast Cancer

Triple Negative Breast Cancer

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

[68Ga]Ga-NNS309

[177Lu]Lu-NNS309

Study Details

Brief summary:

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).

Conditions

Pancreatic Ductal Adenocarcinoma

Non-small Cell Lung Cancer

HR+/HER2- Ductal and Lobular Breast Cancer

Triple Negative Breast Cancer

Colorectal Cancer

Study ID

NCT06562192

Start date

Oct 15, 2024

Status verified date

Jul, 2026

Completion date

Jan 16, 2031

Anticipated

Primary completion date

Jan 15, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

162 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

Patients will receive \[68Ga\]Ga-NNS309, and if eligible, \[177Lu\]Lu-NNS309

Interventions

[68Ga]Ga-NNS309

Radioligand imaging agent

[177Lu]Lu-NNS309

Radioligand therapy

Primary outcome measure

  • Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks ]
  • Dose intensity for [177Lu]Lu-NNS309 [ Time Frame: From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

Uni of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Quenteeria Mooney

qmooney@uabmc.edu

Principal Investigator:

Jonathan McConathy

University of California LA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Angela Lool

alool@mednet.ucla.edu

Principal Investigator:

Jonathan W Goldman

Stanford University Medical Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Maria Isabel Leonio

ileonio@stanford.edu

Principal Investigator:

Farshad Moradi

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Alberta Lalljie

+1 904 953 7648Lalljie.Albertha@mayo.edu

Principal Investigator:

Ephraim Parent

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jonathan Robert Kim

jkim215@mgh.harvard.edu

Principal Investigator:

Shadi Abdar Esfahani

BAMF Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Lisa Orange

lisa.orange@bamfhealth.com

Principal Investigator:

Brandon Mancini

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Lucas Hamann

+1 507 538 2155hamann.lucas@mayo.edu

Principal Investigator:

Andrea Wahner Hendrickson

Uni Of TX MD Anderson Cancer Cntr

Recruiting

Houston, Texas, United States, 77030

Contacts

Denisse Harkins

+1 713 792 2921dvelazquez1@mdanderson.org

Principal Investigator:

Jordi Rodon

University Of Washington

Recruiting

Seattle, Washington, United States, 98109

Contacts

Heather White

hwhite@fredhutch.org

Principal Investigator:

Delphine Chen

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H2X 1R9

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H3T 1E2

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • pancreatic ductal adenocarcinoma
  • non-small cell lung cancer
  • breast cancer
  • colorectal cancer
  • radioligand therapy (RLT)
  • [177Lu]Lu-NNS309
  • [68Ga]Ga-NNS309

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-29.