ClinicalTrials.gg
RecruitingNCT07630961Updated Aug 27, 2026

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

A Phase 1 interventional study of 68Ga-DFC413 and 68Ga-NNS309 in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Non-small Cell Lung Cancer (NSCLC) and HR+/HER2- Ductal Breast Cancer (BC), sponsored by Novartis Pharmaceuticals. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
66
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 95 studies in Carcinoma, Non-Small-Cell Lung by Novartis Pharmaceuticals — 8 open to participants now, 15 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Novartis Pharmaceuticals.

Planned enrollment
51st of 86
66 · median 92
Started
2026
with 4 others
Phase 1
33 of 95
6 open now
Primary completion
2028-01
later than 7 of 14 live
Registered
93rd of 95
by date

Among the 95 studies in Carcinoma, Non-Small-Cell Lung by Novartis Pharmaceuticals, this one is the 51st largest by planned enrollment of the 86 interventional ones that give a count, is one of 5 that started in 2026, is one of 33 in phase 1, reaches primary completion later than 7 of the 14 other live ones, and was the 93rd registered.

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

8 of the 95 studies in Carcinoma, Non-Small-Cell Lung by Novartis Pharmaceuticals are open now, in 12 countries. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Who these studies take

Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 95 studies in Carcinoma, Non-Small-Cell Lung by Novartis Pharmaceuticals, or all of them as a file.
02

Study 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), 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.

03

Conditions studied

  • 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)

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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients eligible for inclusion in this study must meet all of the following criteria:

  1. Signed must be obtained prior to participation in the study.
  2. Age ≥ 18 years old.
  3. performance status ≤ 2.
  4. Patients with one of the following indications (regardless of ):

    Locally advanced unresectable or PDAC, NSCLC, HR+/- ductal or lobular BC, TNBC, CRC or STS.

  5. Patients must have at least one per v1.1 as measured by local Investigator (by conventional MRI or CT scan).
  6. Patients must have an available 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.

Exclusion criteria

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for inclusion in this study:

  1. Out-of-range laboratory values defined as:

    • Estimated \< 60 mL/min (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)
    • Total > 1.5 x (except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 x ULN) or direct bilirubin > 1.5 x ULN
    • (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
    • \< 1.0 x 109/L
    • \< 9 g/dL
    • count \< 75 x 109/L
  2. 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.
  3. Known to 68Ga-DFC413 or 68Ga-NNS309 or their .
  4. 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.
  5. Surgery or major invasive procedure within 4 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
  6. Radiation therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
  7. Change in anticancer therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
  8. Radiological contrast administration within 48 hours prior to 68Ga-DFC413 or 68Ga-NNS309 administration.
  9. Initiation or increasing doses of , TGF-β signaling inhibitors or immunomodulators within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.
  10. Known additional that is progressing or requires active treatment.
  11. Inability to complete the required and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).
  12. Presence of 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.
  13. 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.
  14. 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.
  15. 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.
  16. Women of (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use highly effective methods of (failure rate \<1% per year) for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309.

    Women are considered 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 (IC).

  17. 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.

Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Part 1: Imaging Characterization

    Single dose of 68Ga-DFC413

    Drug: 68Ga-DFC413

  • Experimental
    Part 2: Comparative Assessment

    Single dose of 68Ga-DFC413 followed by 68Ga-NNS309; or single dose of 68Ga-NNS309 followed by 68Ga-DFC413

    Drug: 68Ga-DFC413 · Drug: 68Ga-NNS309

Interventions

  • Drug68Ga-DFC413

    Radioimaging agent

  • Drug68Ga-NNS309

    Radioimaging agent

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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).

    Time frame: 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.

    Time frame: Up to 240 minutes after administration of each imaging agent

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 3 days after administration of each imaging agent

07

Study locations

2 of 2 sites recruiting
  • Novartis Investigative Site
    Odense C, 5000, Denmark
    Recruiting
  • Novartis Investigative Site
    Chuo Ku, Tokyo 1040045, Japan
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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/.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jan 2028, 18 months after the start.

Of 473 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's planned 18 months is below that.

Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2026
First posted
Jun 5, 2026
StartActual
Jun 23, 2026
Primary completionEst.
Jan 16, 2028
CompletionEst.
Jan 16, 2028
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07630961
Responsible party
Sponsor
First posted
Jun 5, 2026
Start date
Jun 23, 2026
Primary completion
Jan 16, 2028 (estimated)
Completion
Jan 16, 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
1-888-669-6682
Novartis Pharmaceuticals
Contact
+41613241111

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion