Pancreatic Ductal AdenocarcinomaPhase 1NCT07261631
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
A Phase 1 study testing 68Ga-NNS309 and 177Lu-DFC413 in people with Pancreatic Ductal Adenocarcinoma and Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 9 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- 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-NNS309 and 177Lu-DFC413
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 9 sitesin 7 countries
- Study dates
- 24 Nov 2025to 9 May 2029
- Phase
- Phase 1
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years with one of the following indications:
- Locally advanced unresectable or metastatic PDAC, with disease progression following, or intolerance to cytotoxic therapy, 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 chemotherapy and targeted therapy, unless patient was ineligible to receive such therapy
- Locally advanced unresectable or metastatic HR+/HER2- ductal and lobular breast cancer with disease progression following, or intolerance to, hormone therapy and CDK inhibitor, and at least one additional line of therapy, unless patient was ineligible to receive such therapy
- Locally advanced unresectable or metastatic triple negative breast cancer (TNBC) with disease progression following, or intolerance to, at least two 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
- (Dose expansion only) Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi) with disease progression following, or intolerance to, at least one line of systemic therapy
- Patients must have lesions showing 68Ga-NNS309 uptake
Who cannot join
- Absolute neutrophil count (ANC) < 1.5 x 109/L, hemoglobin < 9 g/dL, or platelet count < 100 x 109/L
- QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
- eGFR < 60 mL/min/1.73m2, calculated using CKD-EPI 2021 or measured
- Unmanageable urinary tract obstruction or urinary incontinence
- Presence of symptomatic CNS metastases, or CNS metastases that require local CNS-directed therapy
- Any prior radioligand therapy
- Radiation therapy within 4 weeks prior to the first dose of [177Lu]Lu-DFC413
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
9 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 7 countries
Israel2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Haifa, 3109601
- Recruiting
Novartis Investigative Site
Tel Aviv, 6423906
Singapore2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Singapore, 119228
- Recruiting
Novartis Investigative Site
Singapore, 168583
United States1 site, 1 recruiting
- Recruiting
United Theranostics
Princeton, New Jersey, 08540
Jessica DeBerry, +1 609 300 2858, jdeberry@unithera.com
Munir Ghesani
Canada1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Denmark1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Odense C, 5000
France1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Vandœuvre-lès-Nancy, 54511
Germany1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Essen, 45147
About this study
Official title: A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DFC413 and Safety and Imaging Properties of [68Ga]Ga-NNS309 in Patients With Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with solid tumors
Read the detailed description
GCJ904A12101 is first-in-human (FIH), phase I, open label study that consists of a dose escalation part followed by a dose expansion part. In both parts of the study, patients will initially be imaged with a 68Ga-NNS309 positron emission tomography (PET)/ computed tomography (CT) or PET/magnetic resonance imaging (MRI) scan and will be evaluated for eligibility for 177Lu-DFC413 treatment. Patients eligible for treatment will receive 177Lu-DFC413. In the escalation part, different doses of 177Lu-DFC413 will be tested to assess its safety, tolerability, and dosimetry and identify the recommended radioactive administered dose(s) (RD(s)) for further evaluation. The expansion will include arms based on tumor type. 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 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, Soft Tissue Sarcoma
- Being tested
- 68Ga-NNS309, 177Lu-DFC413
- Keywords
- PDAC, NSCLC, Breast cancer, CRC, STS, Radioligand therapy (RLT)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Sarcoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NNS309Drug
Diagnostic investigational radiopharmaceutical
177Lu-DFC413Drug
Therapeutic investigational radiopharmaceutical
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients will receive 68Ga-NNS309 and only patients with tumor uptake will receive 177Lu-DFC413 Receives: Drug: 68Ga-NNS309; Drug: 177Lu-DFC413 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of dose limiting toxicities of 177Lu-DFC413
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: Within first treatment cycle, up to maximum 6 weeks
Incidence and severity of adverse events and serious adverse events of 177Lu-DFC413
The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs) and Serious Adverse Event (TESAEs) and through the monitoring of relevant clinical and laboratory safety parameters.
Measured: From study treatment start up to approximately 42 months
Dose modifications for 177Lu-DFC413
Dose modifications (dose interruptions and reductions) for 177Lu-DFC413 will be assessed and summarized using descriptive statistics. The number of patients with dose modification and the reasons will be summarized by treatment groups.
Measured: From study treatment start until last dose of study treatment, assessed up to approximately 24 weeks
Dose intensity for 177Lu-DFC413
Dose intensity for 177Lu-DFC413 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 study treatment start until last dose of study treatment, assessed up to approximately 24 weeks
Secondary outcomes (15)
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: From study treatment start up to 6 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: From study treatment start up to 6 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: From study treatment start up to 6 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: From study treatment start up to 6 months
Area Under the Curve (AUC) of 177Lu-DFC413
The 177Lu-DFC413 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: Up to 8 days after first dose
Total body clearance of 177Lu-DFC413
The 177Lu-DFC413 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: Up to 8 days after first dose
Observed maximum blood concentration (Cmax) of 177Lu-DFC413
The 177Lu-DFC413 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: Up to 8 days after first dose
Observed maximum radioactivity concentration (Rmax) of 177Lu-DFC413
The 177Lu-DFC413 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: Up to 8 days after first dose
Volume of distribution (Vz) of 177Lu-DFC413 during the terminal phase
The 177Lu-DFC413 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: Up to 8 days after first dose
Terminal elimination half-life (T1/2) of 177Lu-DFC413
The 177Lu-DFC413 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: Up to 8 days after first dose
Urinary excretion of radioactivity expressed as a percentage of injected dose (%ID)
Urine elimination data for 177Lu-DFC413 will be assessed based on decay-corrected urine radioactivity concentration data. Urine elimination data will be expressed as percentage of injected dose (%ID).
Measured: Up to 3 days after first dose
Renal clearance of 177Lu-DFC413
Urine samples will be collected over specified time intervals and analyzed for radioactivity. Renal clearance of 177Lu-DCF413 will be summarized using descriptive statistics.
Measured: Up to 3 days after first dose
Absorbed dose of 177Lu-DFC413
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: Up to 8 days after first dose
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: Up to 3 days after administration
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: Up to 3 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start24 Nov 2025
- Primary completion9 May 2029 (estimated)
- Study completion9 May 2029 (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
- 180 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
- NCT07261631
- Sponsor's protocol ID
- CGCJ904A12101
- Other IDs
- 2025-521702-18, 2025
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.