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Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1NCT07630961

Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors

A Phase 1 study testing 68Ga-DFC413 and 68Ga-NNS309 in people with Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) and Non-small Cell Lung Cancer (NSCLC), run by Novartis Pharmaceuticals at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of [68Ga]Ga-DFC413, and in Part 2 compare to [68Ga]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
68Ga-DFC413 and 68Ga-NNS309
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
2 sitesin 2 countries
Study dates
23 Jun 2026to 16 Jan 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients eligible for inclusion in this study must meet all of the following criteria:
  • Signed informed consent must be obtained prior to participation in the study.
  • Age ≥ 18 years old.
  • ECOG performance status ≤ 2.
  • Patients with one of the following indications (regardless of lines of prior therapy):
  • Locally advanced unresectable or metastatic PDAC, NSCLC, HR+/HER2- ductal or lobular BC, TNBC, CRC or STS.
  • Patients must have at least one measurable lesion per RECIST v1.1 as measured by local Investigator (by conventional MRI or CT scan).
  • Patients must have an available archival tumor sample at the screening visit. If multiple archival tumor samples are available, the most recent will be requested. Exceptions may be made after documented discussion with Novartis.

Who cannot join

  • Patients meeting any of the following criteria are not eligible for inclusion in this study:
  • Out-of-range laboratory values defined as:
  • Estimated glomerular filtration rate < 60 mL/min (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)
  • Total bilirubin > 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN) or direct bilirubin > 1.5 x ULN
  • Alanine aminotransferase (ALT) > 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT > 5.0 x ULN
  • Aspartate aminotransferase (AST) > 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if AST > 5.0 x ULN
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  • Absolute Neutrophil Count < 1.0 x 109/L
  • Hemoglobin < 9 g/dL
  • Platelet count < 75 x 109/L
  • Unmanageable urinary tract obstruction or urinary incontinence. If ureteral obstruction can be managed with the placement of ureteral stents, this exclusion criterion does not apply.
  • Known hypersensitivity to 68Ga-DFC413 or 68Ga-NNS309 or their excipients.
  • Any serious uncontrolled infection (acute or chronic), such as, but not limited to, bacterial, viral or fungal infections, confirmed by clinical evidence, imaging, and/or relevant positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA). If a serious infection develops, it must resolve or be adequately controlled prior to 68Ga-DFC413 and/or 68Ga-NNS309 initiation.
  • Surgery or major invasive procedure within 4 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
  • Radiation therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
  • Change in anticancer therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
  • Radiological contrast administration within 48 hours prior to 68Ga-DFC413 or 68Ga-NNS309 administration.
  • Initiation or increasing doses of corticosteroids, TGF-β signaling inhibitors or immunomodulators within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
  • Known additional malignancy that is progressing or requires active treatment.
  • Inability to complete the required investigational and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).
  • Presence of CTCAE version 5.0 ≥ Grade 2 toxicity due to prior cancer therapy, except for neuropathy (inclusion of patients with neuropathy of ≤ Grade 2 is permitted) and alopecia.
  • Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures (including radiation safety precautions), or interpretation of study results.
  • Pregnant women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
  • Nursing (breast-feeding) women. Women who do not breast feed for 12 hours after 68Ga-DFC413 and/or 68Ga-NNS309 administration, but express and discard breast milk, are eligible.
  • Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use highly effective methods of contraception (failure rate <1% per year) for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309.
  • Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
  • Highly effective contraception methods include:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Bilateral tubal ligation, female sterilization (have had bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking 68Ga-DFC413 or 68Ga-NNS309. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.
  • Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.
  • Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example, hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
  • If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent (IC).
  • Sexually active males unwilling to use a condom during intercourse for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309. A condom is required for all sexually active male patients to prevent them from fathering a child and/or to prevent delivery of study treatment via seminal fluid to their partner. In addition, male patients must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the IC.
  • Other protocol-defined inclusion/exclusioncriteria may apply.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

2 sites in 2 countries

Denmark1 site, 1 recruiting

  • Novartis Investigative Site

    Odense C, 5000

    Recruiting

Other trials in Denmark

Japan1 site, 1 recruiting

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 1040045

    Recruiting

Other trials in Japan

About this study

Official title: Phase I, Open Label First in Human Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of JFI447 [68Ga]Ga-DFC413, and Compare to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors

The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of [68Ga]Ga-DFC413, and in Part 2 compare to [68Ga]Ga-NNS309 in patients 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), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of [68Ga]Ga-DFC413 and [68Ga]Ga-NNS309), not all indications might be explored.

Read the detailed description

This is a first-in-human (FiH), open-label, multicenter, phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, pharmacokinetics (PK), and dosimetry properties of 68Ga-DFC413 and to explore whether 68Ga-DFC413 can be used to identify FAP-expressing lesions in patients with various solid tumors, including metastatic PDAC, NSCLC, ductal and lobular BC, TNBC, CRC, and STS.

The study is divided in 2 parts: An imaging characterization part (Part 1) and a comparative assessment part (Part 2). All patients in Part 1 (imaging characterization part) will receive a single administered radioactive dose of 68Ga-DFC413. In Part 2 (comparative assessment part) patients will either receive a single administered radioactive dose of 68Ga-DFC413 followed by a single administered radioactive dose of 68Ga-NNS309; or a single administered radioactive dose of 68Ga-NNS309 followed by 68Ga-DFC413.

Being tested
68Ga-DFC413, 68Ga-NNS309
Keywords
metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+/HER2- ductal breast cancer (BC), HR+/HER2- lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), soft tissue sarcoma (STS), radioligand imaging
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Colorectal Neoplasms, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-DFC413Drug

    Radioimaging agent

  • 68Ga-NNS309Drug

    Radioimaging agent

Study groups in NCT07630961
Study groupRoleWhat they receive
Part 1: Imaging CharacterizationExperimentalSingle dose of 68Ga-DFC413
Receives: Drug: 68Ga-DFC413
Part 2: Comparative AssessmentExperimentalSingle dose of 68Ga-DFC413 followed by 68Ga-NNS309; or single dose of 68Ga-NNS309 followed by 68Ga-DFC413
Receives: Drug: 68Ga-DFC413; Drug: 68Ga-NNS309

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Standard Uptake Value (SUV) of 68Ga-DFC413 uptake in organs and tumors over time

    Imaging properties of 68Ga-DFC413 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUV values will be calculated and reported with summary statistics.

    Measured: Up to 240 minutes after 68Ga-DFC413 administration

  2. Part 1: Standard Uptake Value ratio (SUVr) of 68Ga-DFC413 uptake

    SUVr will be calculated by dividing the SUV of the lesions by the SUV of the different organs in order to identify the reference organ with the lowest uptake and the respective SUVr (i.e. using SUVmean or SUVmax).

    Measured: Up to 240 minutes after 68Ga-DFC413 administration

  3. Part 2: Agreement between 68Ga-DFC413 and 68Ga-NNS309 for assessing target lesions from both PET scans per disease group

    Agreement between target lesions and normal organs from 68Ga-DFC413 and 68Ga-NNS309 PET imaging will be assessed using summary statistics of SUV and SUVr.

    Measured: Up to 240 minutes after administration of each imaging agent

Secondary outcomes (9)

  1. Part 1: Observed maximum concentration (Cmax) of 68Ga-DFC413 based on blood radioactivity data

    The pharmacokinetic analysis of 68Ga-DFC413 will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples.

    Measured: Up to 240 minutes after 68Ga-DFC413 administration

  2. Part 1: Time to reach maximum concentration (Tmax) of 68Ga-DFC413 based on blood radioactivity data

    The pharmacokinetic analysis of 68Ga-DFC413 will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples.

    Measured: Up to 240 minutes after 68Ga-DFC413 administration

  3. Part 1: Area under the concentration-time curve (AUC) of 68Ga-DFC413 based on blood radioactivity data

    The pharmacokinetic analysis of 68Ga-DFC413 will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples.

    Measured: Up to 240 minutes after 68Ga-DFC413 administration

  4. Part 1: Urinary excretion of 68Ga-DFC413

    The elimination of the compound in urine will be evaluated based on urine radioactivity concentration data obtained by measuring in gamma counting equipment the urine samples.

    Measured: Up to 240 minutes after 68Ga-DFC413 administration

  5. Part 1: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of 68Ga-DFC413

    Incidence and severity of AEs and SAEs after administration of 68Ga-DFC413, including changes in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs.

    Measured: Up to 3 days after administration of each imaging agent

  6. Part 1: Absorbed radiation dose in total body

    Absorbed radiation dose in total body as measured by image quantification.

    Measured: Up to 240 minutes after 68Ga-DFC413 administration

  7. Part 1: Effective radiation dose

    Effective radiation dose in total body as measured by image quantification.

    Measured: Up to 240 minutes after 68Ga-DFC413 administration

  8. Part 2: Number of FAP positive lesions that are detected using 68Ga-DFC413 and 68Ga-NNS309 PET imaging, and conventional imaging methods

    Numbers of Fibroblast Activation Protein (FAP) positive lesions detected by each imaging method.

    Measured: Up to 240 minutes after administration of each imaging agent

  9. Part 2: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of 68Ga-DFC413 and 68Ga-NNS309

    Incidence and severity of AEs and SAEs after administration of 68Ga-DFC413 followed by 68Ga-NNS309 (and vice versa), including changes in vital signs, electrocardiograms and laboratory values qualifying and reported as AEs.

    Measured: Up to 3 days after administration of each imaging agent

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study start23 Jun 2026
  3. Primary completion16 Jan 2028 (estimated)
  4. Study completion16 Jan 2028 (estimated)

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07630961
Sponsor's protocol ID
CJFI447A02101
Other IDs
2025-523665-24, 2025
Status last verified
Aug 2026
First submitted
1 Jun 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
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/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 68Ga-DFC413 and 68Ga-NNS309 in people with Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) and Non-small Cell Lung Cancer (NSCLC), run by Novartis Pharmaceuticals at 2 sites in 2 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 33 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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark, Japan. 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?

Part 1: Standard Uptake Value (SUV) of 68Ga-DFC413 uptake in organs and tumors over time (time frame: Up to 240 minutes after 68Ga-DFC413 administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07630961.

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 27 Aug 2026.

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