Advanced Gastroesophageal AdenocarcinomaPhase 1NCT07801508
A Study of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
A Phase 1 study testing [68Ga]Ga-DWJ155 in people with Advanced Gastroesophageal Adenocarcinoma and Advanced Breast Cancer, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastroesophageal Adenocarcinoma, Advanced Breast Cancer, Triple-negative Breast Cancer
- What is being tested?
- [68Ga]Ga-DWJ155
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Sep 2026to 30 Jun 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
- Age ≥ 18 years old
- Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients with one of the following indications:
- HR+/HER2- aBC and TNBC: untreated or currently receiving or having completed first line of systemic therapy (preferred); HER2+ aBC: regardless of any prior systemic therapy
- aNSCLC adenocarcinoma: Prior to, during or having completed their first line of systemic therapy. If HER2 immunohistochemistry (IHC) will be routinely performed and available, then HER2 ≥1+
- aGEA: regardless of any prior systemic line of therapy
Who cannot join
- Out-of-range laboratory values defined as:
- Estimated glomerular filtration rate (eGFR; calculated using CKD-EPI 2021 formula, or measured) < 40 mL/min/1.73m2
- Platelet count < 75 x 10^9/L
- Hemoglobin < 9 g/dL
- Absolute neutrophil count (ANC) < 1.0 x 10^9/L
- Patients with inadequate hepatic function
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- Urinary tract obstruction or urinary incontinence
- Pregnant or breastfeeding women
- Other protocol-defined inclusion/exclusion criteria 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
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
About this study
Official title: A Phase I, Open Label Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
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.
Read the detailed description
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.
- Conditions
- Advanced Gastroesophageal Adenocarcinoma, Advanced Breast Cancer, Triple-negative Breast Cancer, Advanced Non-small Cell Lung Cancer
- Being tested
- [68Ga]Ga-DWJ155
- Keywords
- Gastroesophageal adenocarcinoma (GEA), Gastric cancer (GC), Breast cancer (BC), Non-small cell lung cancer (NSCLC), Radioligand imaging (RLI), [68Ga]Ga-DWJ155, FKL480, Gallium, Adenocarcinoma, Positron emission tomography (PET), Dosimetry, HER2, Radiopharmaceutical
- Medical subject headings
- Triple Negative Breast Neoplasms, Stomach Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-DWJ155Diagnostic test
Also called FKL480
Radioligand imaging agent
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-DWJ155 | Experimental | Single administration of [68Ga]Ga-DWJ155 Receives: Diagnostic Test: [68Ga]Ga-DWJ155 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start8 Sep 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastroesophageal 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT07801508
- Sponsor's protocol ID
- CFKL480A02102
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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/.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT07801508
- Acronym / sponsor ID
- CFKL480A02102
- Conditions
- Advanced Gastroesophageal Adenocarcinoma, Advanced Breast Cancer, Triple-negative Breast Cancer, Advanced Non-small Cell Lung Cancer
- Keywords
- Gastroesophageal adenocarcinoma (GEA), Gastric cancer (GC), Breast cancer (BC), Non-small cell lung cancer (NSCLC), Radioligand imaging (RLI), [68Ga]Ga-DWJ155, FKL480, Gallium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 3 Sep 2026 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-DWJ155 | Experimental | Diagnostic Test: [68Ga]Ga-DWJ155Single administration of [68Ga]Ga-DWJ155 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old
- Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients with one of the following indications:
Key exclusion criteria (9 listed)
- Out-of-range laboratory values defined as:
- Patients with inadequate hepatic function
- Urinary tract obstruction or urinary incontinence
- Pregnant or breastfeeding women
- Other protocol-defined inclusion/exclusion criteria may apply.
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-DWJ155Also: FKL480Radioligand imaging agent | Diagnostic test | [68Ga]Ga-DWJ155 |
Primary outcome
Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.
Standardized uptake value ratio (SUVr) of [68Ga]Ga-DWJ155 in tumor lesions relative to reference organs
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Standardized uptake value ratios (SUVr) will be calculated as the ratio of SUV in tumor lesions to SUV in normal organs.
5 secondary outcomes
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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)
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)
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)
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
Effective radiation dose (Imaging characterization part only)
Time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155
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 13 Oct 2026.
- Individual participant dataSharing planned: 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/.
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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.
Novartis Pharmaceuticals contact
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [68Ga]Ga-DWJ155 in people with Advanced Gastroesophageal Adenocarcinoma and Advanced Breast Cancer, 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 7 inclusion and 9 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 13 Oct 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 Australia, 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 (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard uptake values (SUVs) of [68Ga]Ga-DWJ155 in selected organs, normal tissue and tumor lesions (time frame: Up to 180 minutes after the end of injection of [68Ga]Ga-DWJ155). The study lists 2 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 13 Oct 2026.