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Clinical Trials in Belgium / NCT06562192
Recruiting Phase 1

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

NCT06562192 · tracked via the Priya Life Science Belgium tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 1
Started
2024-10-15
Last updated
2026-07-29

Condition(s) studied

Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerHR+/HER2- Ductal and Lobular Breast CancerTriple Negative Breast CancerColorectal Cancer

Investigational drug(s) / intervention(s)

[68Ga]Ga-NNS309[177Lu]Lu-NNS309

[68Ga]Ga-NNS309: Radioligand imaging agent

[177Lu]Lu-NNS309: Radioligand therapy

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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
    A dose limiting toxicity (DLT) is defined as any adverse event or abnormal laboratory value of CTCAE (version 5.0) Grade 3 or higher that occurs within the DLT evaluation period and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with a few exceptions defined in the study protocol. Other clinically significant toxicities may be considered to be DLTs, even if not Grade 3 or higher.
  • 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
    The distribution of adverse events will be done via the analysis of frequencies for treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) and through the monitoring of relevant clinical and laboratory safety parameters.
  • Dose modifications for [177Lu]Lu-NNS309 — From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks
    Dose modifications (dose interruptions and reductions) for \[177Lu\]Lu-NNS309 will be assessed and summarized using descriptive statistics. The number of patients with dose modification will be summarized by treatment groups.
  • Dose intensity 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 will be assessed and summarized using descriptive statistics. Dose intensity is computed as the ratio of actual cumulative dose received and actual duration of exposure.

Trial sites (29)

FacilityCityRegionStatus
Uni of Alabama at Birmingham Birmingham Alabama Recruiting
University of California LA Los Angeles California Recruiting
Stanford University Medical Center Palo Alto California Recruiting
Mayo Clinic Jacksonville Jacksonville Florida Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
BAMF Health Grand Rapids Michigan Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Uni Of TX MD Anderson Cancer Cntr Houston Texas Recruiting
University Of Washington Seattle Washington Recruiting
Novartis Investigative Site Brussels Belgium Recruiting
Novartis Investigative Site Toronto Ontario Recruiting
Novartis Investigative Site Montreal Quebec Recruiting
Novartis Investigative Site Montreal Quebec Recruiting
Novartis Investigative Site Bron France Recruiting
Novartis Investigative Site Villejuif France Recruiting
Novartis Investigative Site Cologne North Rhine-Westphalia Recruiting
Novartis Investigative Site Essen Germany Recruiting
Novartis Investigative Site München Germany Recruiting
Novartis Investigative Site Rostock Germany Recruiting
Novartis Investigative Site Tel Aviv Israel Recruiting
Novartis Investigative Site Milan MI Recruiting
Novartis Investigative Site Reggio Emilia RE Recruiting
Novartis Investigative Site Nijmegen Gelderland Recruiting
Novartis Investigative Site Utrecht Netherlands Recruiting
Novartis Investigative Site Barcelona Spain Recruiting
Novartis Investigative Site Madrid Spain Recruiting
Novartis Investigative Site Madrid Spain Recruiting
Novartis Investigative Site Geneva Switzerland Recruiting
Novartis Investigative Site Lausanne Switzerland Recruiting

More Novartis Pharmaceuticals trials in Belgium

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An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Active, not recruiting
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) Active, not recruiting
An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. Recruiting
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients Active, not recruiting

Other trials for the same condition

Anvumetostat Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) (MTAPESTRY 104). Active, not recruiting
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types Recruiting
Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671) Active, not recruiting
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) Active, not recruiting
Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06562192 on ClinicalTrials.gov ↗ ← All trials in Belgium