A Phase 1 interventional study of [68Ga]Ga-DWJ155 in Advanced Gastroesophageal Adenocarcinoma, Advanced Breast Cancer and Triple-negative Breast Cancer, sponsored by Novartis Pharmaceuticals. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Diagnostic
Among 22 studies in Triple Negative Breast Neoplasms by Novartis Pharmaceuticals — 4 open to participants now, 6 under way, none of them phase 3. Triple Negative Breast Neoplasms · Novartis Pharmaceuticals.
Among the 22 studies in Triple Negative Breast Neoplasms by Novartis Pharmaceuticals, this one is the 17th largest by planned enrollment, is one of 2 that started in 2026, is one of 14 in phase 1, and was the 22nd registered.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
Browse Triple Negative Breast Neoplasms studies →4 of the 22 studies in Triple Negative Breast Neoplasms by Novartis Pharmaceuticals are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Denmark, Japan
Novartis Pharmaceuticals · Sites in United States, Canada, Denmark and 4 more countries
Novartis Pharmaceuticals · Sites in United States, Belgium, Canada and 7 more countries
By country, each count listing its studies:
Of the 332 Triple Negative Breast Neoplasms studies recruiting now, 232 (70%) set no upper age limit and 85 (26%) stop at 75 or younger; 12 take children under 18; 6 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.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 7 · Phase 3 1
First in 2010; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 66 is close to the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Median enrollment 132 across the 22 interventional studies. Of the 15 that completed or were terminated, 7 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
2 of the studies in Triple Negative Breast Neoplasms by Novartis Pharmaceuticals that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03891953Novartis PharmaceuticalsStudy of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. | 2027-06-25 |
| NCT05544929Novartis PharmaceuticalsA Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers | 2027-10-05 |
Among the 22 studies in Triple Negative Breast Neoplasms by Novartis Pharmaceuticals, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics (PK) of [68Ga]Ga-DWJ155, also known as FKL480, in patients ≥ 18 years of age with advanced gastroesophageal adenocarcinoma (aGEA, where GEA is defined as adenocarcinomas of the distal esophagus, the gastroesophageal junction, and the stomach), hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative (HR+/HER2-) advanced breast cancer (aBC), HER2 positive (HER2+) aBC, triple-negative breast cancer (TNBC) and advanced non-small cell lung cancer (aNSCLC) adenocarcinoma.
This is an open-label, Phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, pharmacokinetics (PK), and dosimetry properties of [68Ga]Ga-DWJ155.
HER2 status for enrollment will be determined based on the most recent, locally available tumor tissue sample and corresponding HER2 results, in accordance with the American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines, as applicable.
This study comprises an imaging characterization part and an expansion part. During the imaging characterization part, the imaging characteristics of [68Ga]Ga-DWJ155 (e.g., biodistribution, tumor uptake, and radiation dosimetry) will be assessed, as well as the optimal imaging time point for tumor visualization. The expansion part may be initiated if positive tumor uptake is observed in patients during the imaging characterization part.
The estimated study duration for each individual patient is up to approximately 32 days, including a screening period of up to 28 days, a single-day imaging period (including [68Ga]Ga-DWJ155 administration and assessments), and a 3-day safety follow-up.
Key Inclusion Criteria:
Patients with one of the following indications:
Key Exclusion Criteria:
Out-of-range laboratory values defined as:
Other protocol-defined inclusion/exclusion criteria may apply.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single administration of \[68Ga\]Ga-DWJ155
Diagnostic Test: [68Ga]Ga-DWJ155
Radioligand imaging agent
Also known as: FKL480
Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions
Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Standardized uptake value ratio (SUVr) of [68Ga]Ga-DWJ155 in tumor lesions relative to reference organs
Standardized uptake value ratios (SUVr) will be calculated as the ratio of SUV in tumor lesions to SUV in normal organs.
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Time frame: Up to 3 days after the administration of [68Ga]Ga-DWJ155
Area under the concentration-time curve (AUC) of blood radioactivity (Imaging characterization part only)
Pharmacokinetic (PK) analysis will be performed in the imaging characterization part based on decay-corrected blood radioactivity concentration data. These data will be converted to mass units for PK analysis, and AUC will be determined using non-compartmental methods.
Time frame: From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Maximum observed concentration (Cmax) of blood radioactivity (Imaging characterization part only)
PK analysis will be performed in the imaging characterization part based on decay-corrected blood radioactivity concentration data. These data will be converted to mass units for PK analysis, and Cmax will be determined using non-compartmental methods.
Time frame: From pre-dose up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Absorbed radiation dose in selected organs and total body (Imaging characterization part only)
Absorbed radiation dose will be estimated for organs of interest and whole body based on serial positron emission tomography (PET) imaging.
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Effective radiation dose (Imaging characterization part only)
Effective radiation dose will be calculated based on the estimated absorbed radiation doses in source organs, with adjustments for individual body weight and organ masses (derived from computed tomography imaging).
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
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.
Started Sep 2026 (actual). Primary completion is estimated for Jun 2028, 21 months after the start.
Of 135 industry-sponsored phase 1 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 70. This study's planned 21 months is below that.
Counting every sponsor, half of 207 studies reached it within 54 months; a quarter within 35 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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