Pancreatic Ductal AdenocarcinomaPhase 1NCT06562192
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
A Phase 1 study testing [68Ga]Ga-NNS309 and [177Lu]Lu-NNS309 in people with Pancreatic Ductal Adenocarcinoma and Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 29 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer
- What is being tested?
- [68Ga]Ga-NNS309 and [177Lu]Lu-NNS309
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 29 sitesin 10 countries
- Study dates
- 15 Oct 2024to 16 Jan 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
29 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 10 countries
United States9 sites, 9 recruiting
- Recruiting
Uni of Alabama at Birmingham
Birmingham, Alabama, 35249
Quenteeria Mooney, qmooney@uabmc.edu
Jonathan McConathy
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Jonathan Robert Kim, jkim215@mgh.harvard.edu
Shadi Abdar Esfahani
- Recruiting
BAMF Health
Grand Rapids, Michigan, 49503
Lisa Orange, lisa.orange@bamfhealth.com
Brandon Mancini
- Recruiting
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, 77030
Denisse Harkins, +1 713 792 2921, dvelazquez1@mdanderson.org
Jordi Rodon
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Alberta Lalljie, +1 904 953 7648, Lalljie.Albertha@mayo.edu
Ephraim Parent
- Recruiting
University of California LA
Los Angeles, California, 90095
Angela Lool, alool@mednet.ucla.edu
Jonathan W Goldman
- Recruiting
Stanford University Medical Center
Palo Alto, California, 94304
Maria Isabel Leonio, ileonio@stanford.edu
Farshad Moradi
- Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Lucas Hamann, +1 507 538 2155, hamann.lucas@mayo.edu
Andrea Wahner Hendrickson
- Recruiting
University Of Washington
Seattle, Washington, 98109
Heather White, hwhite@fredhutch.org
Delphine Chen
Germany4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Cologne, North Rhine-Westphalia, 50937
- Recruiting
Novartis Investigative Site
Essen, 45147
- Recruiting
Novartis Investigative Site
München, 80377
- Recruiting
Novartis Investigative Site
Rostock, 18057
Canada3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H2X 1R9
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Spain3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, 08036
- Recruiting
Novartis Investigative Site
Madrid, 28009
- Recruiting
Novartis Investigative Site
Madrid, 28040
France2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Bron, 69677
- Recruiting
Novartis Investigative Site
Villejuif, 94800
Italy2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Milan, MI, 20133
- Recruiting
Novartis Investigative Site
Reggio Emilia, RE, 42123
Netherlands2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Nijmegen, Gelderland, 6500HB
- Recruiting
Novartis Investigative Site
Utrecht, 3584 CX
Switzerland2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Geneva, 1211
- Recruiting
Novartis Investigative Site
Lausanne, 1011
Belgium1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Brussels, 1000
Israel1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Tel Aviv, 6423906
About this study
Official title: Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity 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).
Read the detailed description
The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a [68Ga]Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for [177Lu]Lu-NNS309 treatment. In the escalation part, different doses of [177Lu]Lu-NNS309 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of [177Lu]Lu-NNS309 at the RD(s) determined during the escalation part. The end of study will occur when all patients per disease group in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period.
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer
- Being tested
- [68Ga]Ga-NNS309, [177Lu]Lu-NNS309
- Keywords
- pancreatic ductal adenocarcinoma, non-small cell lung cancer, breast cancer, colorectal cancer, radioligand therapy (RLT), [177Lu]Lu-NNS309, [68Ga]Ga-NNS309
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-NNS309Drug
Radioligand imaging agent
[177Lu]Lu-NNS309Drug
Radioligand therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients will receive [68Ga]Ga-NNS309, and if eligible, [177Lu]Lu-NNS309 Receives: Drug: [68Ga]Ga-NNS309; Drug: [177Lu]Lu-NNS309 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicities of [177Lu]Lu-NNS309
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.
Measured: 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
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.
Measured: 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
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.
Measured: From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks
Dose intensity for [177Lu]Lu-NNS309
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.
Measured: From start of study treatment until last dose of study treatment, assessed up to approximately 24 weeks
Secondary outcomes (17)
Overall response rate (ORR)
ORR is defined as the proportion of patients with a BOR of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.
Measured: Up to approximately 42 months
Duration of Response (DOR)
DOR is the time between the first documented response (CR or PR) and the date of progression according to RECIST v1.1 guidelines, or death due to any cause.
Measured: Up to approximately 42 months
Disease control rate (DCR)
DCR is defined as the proportion of patients with a BOR of CR, PR or stable disease according to RECIST v1.1 guidelines.
Measured: Up to approximately 42 months
Progression free survival (PFS)
PFS is defined as the time from the date of start of treatment to the date of the first documented progression according to RECIST v1.1 guidelines or death due to any cause.
Measured: Up to approximately 42 months
Area Under the Curve (AUC) of [177Lu]Lu-NNS309
The [177Lu]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. AUC will be determined by non-compartmental methods.
Measured: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Total body clearance of [177Lu]Lu-NNS309
The [177Lu]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Total body clearance will be determined by non-compartmental methods.
Measured: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Observed maximum blood concentration (Cmax) of [177Lu]Lu-NNS309
The [177Lu]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Cmax will be determined by non-compartmental methods.
Measured: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Observed maximum radioactivity concentration (Rmax) of [177Lu]Lu-NNS309
The [177Lu]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Rmax will be determined by non-compartmental methods.
Measured: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Volume of distribution (Vz) of [177Lu]Lu-NNS309 during the terminal phase
The [177Lu]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Vz will be determined by non-compartmental methods.
Measured: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Terminal elimination half-life (T1/2) of [177Lu]Lu-NNS309
The [177Lu]Lu-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. T1/2 will be determined by non-compartmental methods.
Measured: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Urinary excretion of radioactivity expressed as a percentage of injected dose (%ID)
Urine elimination data for [177Lu]Lu-NNS309 will be assessed based on decay-corrected urine radioactivity concentration data. Urine elimination data will be expressed as percentage of injected dose (%ID).
Measured: Cycle 1: Pre-infusion, beginning of infusion to first SPECT/CT image acquisition, first SPECT/CT image acquisition to 6 hr post end of infusion (EOI), 6-24hr post EOI, 24-48hr post EOI, 48-72hr post EOI. The duration of a cycle is 4 weeks or 6 weeks.
Renal clearance of [177Lu]Lu-NNS309
Urine samples will be collected over specified time intervals and analyzed for radioactivity. Renal clearance of 177Lu-NNS309 will be summarized using descriptive statistics.
Measured: Cycle 1: Pre-infusion, beginning of infusion to first SPECT/CT image acquisition, first SPECT/CT image acquisition to 6 hr post end of infusion (EOI), 6-24hr post EOI, 24-48hr post EOI, 48-72hr post EOI. The duration of a cycle is 4 weeks or 6 weeks.
Absorbed dose of [177Lu]Lu-NNS309
Time activity curves (TACs) for the various organs and tumor lesions will be produced as fraction of injected activity per gram of tissue (%ID/g) as a function of time.
Measured: Samples collected 5 hours to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Absorbed radiation dose of [68Ga]Ga-NNS309 in tumor lesions (dose expansion only)
Time activity curves (TACs) for the tumor lesions will be produced as fraction of injected activity per gram of tissue (%ID/g) as a function of time.
Measured: Samples collected 30 minutes to 3 hours post end of injection.
Area Under the Curve (AUC) of [68Ga]Ga-NNS309
The [68Ga]Ga-NNS309 pharmacokinetic analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. AUC will be determined by non-compartmental methods.
Measured: Samples collected 5 minutes to 245 minutes post end of injection.
Incidence and severity of adverse events and serious adverse events of [68Ga]Ga-NNS309
The distribution of adverse events will be done via the analysis of frequencies for TEAEs and TESAEs and through the monitoring of relevant clinical and laboratory safety parameters.
Measured: From Imaging visit until 3 days after 68Ga-NNS309 administration, assessed up to approximately 3 days.
Visual and quantitative assessment of [68Ga]Ga-NNS309 uptake in normal tissues and tumor lesions over time
After [68Ga]Ga-NNS309 administration, [68Ga]Ga-NNS309 PET/CT or PET/MRI will be performed. Standardized uptake values (SUVs) of [68Ga]Ga-NNS309 in normal tissues and tumor lesions over time will be summarized.
Measured: From 0 up to approximately 3 hrs after [68Ga]Ga-NNS309 dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Oct 2024
- Primary completion15 Jan 2031 (estimated)
- Study completion16 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562192
- Sponsor's protocol ID
- CFXX489A12101
- Other IDs
- 2023-510356-23, 2023
- Status last verified
- Jul 2026
- First submitted
- 16 Aug 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers
- ClinicalTrials.gov ID
- NCT06562192
- Acronym / sponsor ID
- CFXX489A12101
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer, Colorectal Cancer
- Keywords
- pancreatic ductal adenocarcinoma, non-small cell lung cancer, breast cancer, colorectal cancer, radioligand therapy (RLT), [177Lu]Lu-NNS309, [68Ga]Ga-NNS309
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 15 Jan 2031 (estimated)
- Study completion
- 16 Jan 2031 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study will be done in two parts. The first part is called "escalation" and the second part is called "expansion". In both parts of the study, patients will initially be imaged with a [68Ga]Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for [177Lu]Lu-NNS309 treatment. In the escalation part, different doses of [177Lu]Lu-NNS309 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of [177Lu]Lu-NNS309 at the RD(s) determined during the escalation part. The end of study will occur when all patients per disease group in the expansion part have completed the follow-up for disease progression or discontinued from the study for any reason, and all patients have completed treatment and the 36-month long-term follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: [68Ga]Ga-NNS309, Drug: [177Lu]Lu-NNS309Patients will receive [68Ga]Ga-NNS309, and if eligible, [177Lu]Lu-NNS309 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-NNS309Radioligand imaging agent | Drug | Arm 1 |
| [177Lu]Lu-NNS309Radioligand therapy | Drug | Arm 1 |
Primary outcome
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
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
Time frame: 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
Time frame: 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
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 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.
17 secondary outcomes
Overall response rate (ORR)
Time frame: Up to approximately 42 months
Duration of Response (DOR)
Time frame: Up to approximately 42 months
Disease control rate (DCR)
Time frame: Up to approximately 42 months
Progression free survival (PFS)
Time frame: Up to approximately 42 months
Area Under the Curve (AUC) of [177Lu]Lu-NNS309
Time frame: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Total body clearance of [177Lu]Lu-NNS309
Time frame: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Observed maximum blood concentration (Cmax) of [177Lu]Lu-NNS309
Time frame: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Observed maximum radioactivity concentration (Rmax) of [177Lu]Lu-NNS309
Time frame: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Volume of distribution (Vz) of [177Lu]Lu-NNS309 during the terminal phase
Time frame: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Terminal elimination half-life (T1/2) of [177Lu]Lu-NNS309
Time frame: Samples collected pre infusion to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Urinary excretion of radioactivity expressed as a percentage of injected dose (%ID)
Time frame: Cycle 1: Pre-infusion, beginning of infusion to first SPECT/CT image acquisition, first SPECT/CT image acquisition to 6 hr post end of infusion (EOI), 6-24hr post EOI, 24-48hr post EOI, 48-72hr post EOI. The duration of a cycle is 4 weeks or 6 weeks.
Renal clearance of [177Lu]Lu-NNS309
Time frame: Cycle 1: Pre-infusion, beginning of infusion to first SPECT/CT image acquisition, first SPECT/CT image acquisition to 6 hr post end of infusion (EOI), 6-24hr post EOI, 24-48hr post EOI, 48-72hr post EOI. The duration of a cycle is 4 weeks or 6 weeks.
Absorbed dose of [177Lu]Lu-NNS309
Time frame: Samples collected 5 hours to 336 hours post end of infusion in Cycle 1. In a subset of patients, sampling is repeated in Cycle 2 and subsequent cycles. Cycle duration is 4 or 6 weeks.
Absorbed radiation dose of [68Ga]Ga-NNS309 in tumor lesions (dose expansion only)
Time frame: Samples collected 30 minutes to 3 hours post end of injection.
Area Under the Curve (AUC) of [68Ga]Ga-NNS309
Time frame: Samples collected 5 minutes to 245 minutes post end of injection.
Incidence and severity of adverse events and serious adverse events of [68Ga]Ga-NNS309
Time frame: From Imaging visit until 3 days after 68Ga-NNS309 administration, assessed up to approximately 3 days.
Visual and quantitative assessment of [68Ga]Ga-NNS309 uptake in normal tissues and tumor lesions over time
Time frame: From 0 up to approximately 3 hrs after [68Ga]Ga-NNS309 dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
29 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [68Ga]Ga-NNS309 and [177Lu]Lu-NNS309 in people with Pancreatic Ductal Adenocarcinoma and Non-small Cell Lung Cancer, run by Novartis Pharmaceuticals at 29 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Germany, Canada, Spain, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.