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

This study is testing two investigational drugs, [68Ga]Ga-NNS309 and [177Lu]Lu-NNS309, for people aged 18 to 100 with certain advanced pancreatic, lung, breast, or colorectal cancers. The main goal is to see how safe [177Lu]Lu-NNS309 is and what side effects it might cause. Researchers will also look at how the body handles the drug and if it shows any early signs of helping to treat the cancer. You would first have an imaging scan with [68Ga]Ga-NNS309 to see if you are eligible for treatment with [177Lu]Lu-NNS309. This study is looking for 162 participants.

Study design
This is a Phase I interventional study with two parts: an "escalation" part to find the right dose, and an "expansion" part to further evaluate safety and early effectiveness. It is planned to enroll 162 participants.
What's involved
You would first undergo an imaging scan with [68Ga]Ga-NNS309. If eligible, you would then receive treatment with [177Lu]Lu-NNS309, with the duration of treatment assessed up to approximately 24 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and side effects for up to approximately 42 months after starting treatment. Long-term follow-up for disease progression will occur for 36 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06562192

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~162 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:[68Ga]Ga-NNS309[177Lu]Lu-NNS309

At a glance

Recruiting sites
29 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309
Measured over From start of study treatment until 6 weeks or 4 weeks after, depending on dosing schedule
+3 more outcomes measured

Conditions

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

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Breast CarcinomaColorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmGallium Ga 68 NNS309MRC1 wt AlleleMSI1 Gene

Where it's being run

29 sites across 21 states
Germany3
Spain3
California2
Quebec2
France2
Switzerland2
Alabama1
Florida1

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309From 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-NNS309From 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-NNS309From 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-NNS309From 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.