Breast NeoplasmsPhase 1NCT07117214
A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
A Phase 1 study testing [68Ga]Ga-DWJ155 in people with Breast Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Novartis Pharmaceuticals at 1 site in Netherlands.
Trial summary
This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of [68Ga]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative (HR+/HER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- [68Ga]Ga-DWJ155
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Jun 2026to 26 Jan 2029
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Patients with histologically or cytologically confirmed and documented HR+/HER2- advanced breast cancer (aBC), advanced defined as locoregionally advanced unresectable or metastatic, either untreated or currently receiving first line of systemic therapy OR patients with histologically or cytologically confirmed and documented HER2+ aBC, advanced defined as locoregionally advanced unresectable or metastatic, either untreated or relapsed/refractory (r/r) after one or more lines of treatment OR patients with histologically or cytologically confirmed and documented advanced NSCLC (aNSCLC) adenocarcinoma, advanced defined as locoregionally unresectable or metastatic, either untreated or currently receiving first line of systemic therapy.
- Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional CT scan.
Who cannot join
- Patients having out of range laboratory values for kidney function and blood markers as defined in the study protocol
- Patients with inadequate hepatic function
- Unmanageable urinary tract obstruction or urinary incontinence
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Netherlands1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Groningen, Provincie Groningen, 9728 NZ
About this study
Official title: A Phase I, Open Label First in Human Study to Evaluate the Imaging Performance, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Advanced Breast Cancer and Advanced NSCLC
This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of [68Ga]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative (HR+/HER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small Cell Lung Cancer (aNSCLC) adenocarcinoma.
Read the detailed description
This is a first-in-human (FIH), open-label, phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, PK and dosimetry properties in patients with aBC and aNSCLC adenocarcinoma.
Approximately 15-21 aBC and 9-15 aNSCLC patients will be enrolled into the study. All patients enrolled in the study will receive a single administered radioactive dose of FKL480. The study will consist of an imaging characterization part and an expansion part.
- Conditions
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
- Being tested
- [68Ga]Ga-DWJ155
- Keywords
- Breast cancer, Non-small cell lung cancer, Radioligand imaging, [68Ga]Ga-DWJ155, FKL480, gallium, adenocarcinoma, ductal, lobular, positron emission tomography (PET), dosimetry
- Medical subject headings
- 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-DWJ155Drug
Radioligand imaging agent
| Study group | Role | What they receive |
|---|---|---|
| Advanced breast cancer | Experimental | Patients will receive FKL480 ([68Ga]Ga-DWJ155) Receives: Drug: [68Ga]Ga-DWJ155 |
| Advanced NSCLC | Experimental | Patients will receive FKL480 ([68Ga]Ga-DWJ155) Receives: Drug: [68Ga]Ga-DWJ155 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Uptake Value (SUV) mean and max of FKL480 uptake in normal organs and tumor lesions over time
Imaging properties of FKL480 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUVmean and SUVmax will be calculated and reported with summary statistics.
Measured: Up to 240 minutes after dosing on Day 1
Standard Uptake Value ratio (SUVr) of FKL480 uptake in normal organs and tumor lesions over time
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 dosing on Day 1
Secondary outcomes (7)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of AEs and SAEs, including changes in vital signs and laboratory values qualifying and reported as AEs.
Measured: Up to 3 days after single dose administration on Day 1
Dosimetry sub-group: Observed maximum concentration (Cmax) of FKL480 based on blood radioactivity data
The FKL480 pharmacokinetic analysis 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 dosing on Day 1
Dosimetry sub-group: Observed area under the curve (AUC) from time zero to the last measurable concentration sampling time (AUClast) of FKL480 based on blood radioactivity data
The FKL480 pharmacokinetic analysis 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 dosing on Day 1
Dosimetry sub-group: Observed time to reach maximum (Tmax) after single dose administration of FKL480 based on blood radioactivity data
The FKL480 pharmacokinetic analysis 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 dosing on Day 1
Dosimetry sub-group: Urinary excretion of FKL480
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 dosing on Day 1
Dosimetry sub-group: Absorbed radiation dose in normal tissues and total body
Absorbed radiation dose coefficients in selected organs and lesions and total body as measured by image quantification.
Measured: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Effective dose
Effective dose in selected organs and total body as measured by image quantification.
Measured: Up to 240 minutes after dosing on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start26 Jun 2026
- Primary completion26 Jan 2029 (estimated)
- Study completion26 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Imaging study
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT07117214
- Sponsor's protocol ID
- CFKL480A02101
- Other IDs
- 2024-517746-34
- Status last verified
- Aug 2026
- First submitted
- 22 Jul 2025
- Last updated
- 27 Aug 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 www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label First in Human Study to Evaluate the Imaging Performance, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Advanced Breast Cancer and Advanced NSCLC
- ClinicalTrials.gov ID
- NCT07117214
- Acronym / sponsor ID
- CFKL480A02101
- Conditions
- Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
- Keywords
- Breast cancer, Non-small cell lung cancer, Radioligand imaging, [68Ga]Ga-DWJ155, FKL480, gallium, adenocarcinoma, ductal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- 26 Jan 2029 (estimated)
- Study completion
- 26 Jan 2029 (estimated)
- First posted
- 12 Aug 2025 (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.
This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of [68Ga]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive/HER2 negative (HR+/HER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small Cell Lung Cancer (aNSCLC) adenocarcinoma.
Detailed description
This is a first-in-human (FIH), open-label, phase I radioligand imaging study designed to assess the biodistribution, imaging, safety, PK and dosimetry properties in patients with aBC and aNSCLC adenocarcinoma.
Approximately 15-21 aBC and 9-15 aNSCLC patients will be enrolled into the study. All patients enrolled in the study will receive a single administered radioactive dose of FKL480. The study will consist of an imaging characterization part and an expansion part.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Imaging study
| Arm | Type | Receives |
|---|---|---|
| Advanced breast cancer | Experimental | Drug: [68Ga]Ga-DWJ155Patients will receive FKL480 ([68Ga]Ga-DWJ155) |
| Advanced NSCLC | Experimental | Drug: [68Ga]Ga-DWJ155Patients will receive FKL480 ([68Ga]Ga-DWJ155) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Patients with histologically or cytologically confirmed and documented HR+/HER2- advanced breast cancer (aBC), advanced defined as locoregionally advanced unresectable or metastatic, either untreated or currently receiving first line of systemic therapy OR patients with histologically or cytologically confirmed and documented HER2+ aBC, advanced defined as locoregionally advanced unresectable or metastatic, either untreated or relapsed/refractory (r/r) after one or more lines of treatment OR patients with histologically or cytologically confirmed and documented advanced NSCLC (aNSCLC) adenocarcinoma, advanced defined as locoregionally unresectable or metastatic, either untreated or currently receiving first line of systemic therapy.
- Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional CT scan.
Key exclusion criteria (4 listed)
- Patients having out of range laboratory values for kidney function and blood markers as defined in the study protocol
- Patients with inadequate hepatic function
- Unmanageable urinary tract obstruction or urinary incontinence
- 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-DWJ155Radioligand imaging agent | Drug | Advanced NSCLC, Advanced breast cancer |
Primary outcome
Standard Uptake Value (SUV) mean and max of FKL480 uptake in normal organs and tumor lesions over time
Time frame: Up to 240 minutes after dosing on Day 1
Imaging properties of FKL480 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUVmean and SUVmax will be calculated and reported with summary statistics.
Standard Uptake Value ratio (SUVr) of FKL480 uptake in normal organs and tumor lesions over time
Time frame: Up to 240 minutes after dosing on Day 1
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).
7 secondary outcomes
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 3 days after single dose administration on Day 1
Dosimetry sub-group: Observed maximum concentration (Cmax) of FKL480 based on blood radioactivity data
Time frame: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Observed area under the curve (AUC) from time zero to the last measurable concentration sampling time (AUClast) of FKL480 based on blood radioactivity data
Time frame: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Observed time to reach maximum (Tmax) after single dose administration of FKL480 based on blood radioactivity data
Time frame: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Urinary excretion of FKL480
Time frame: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Absorbed radiation dose in normal tissues and total body
Time frame: Up to 240 minutes after dosing on Day 1
Dosimetry sub-group: Effective dose
Time frame: Up to 240 minutes after dosing on Day 1
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 27 Aug 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 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
1 site in 1 country: 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 Breast Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Novartis Pharmaceuticals at 1 site in Netherlands.
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 3 inclusion and 4 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 1 site in Netherlands. 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 Value (SUV) mean and max of FKL480 uptake in normal organs and tumor lesions over time (time frame: Up to 240 minutes after dosing on Day 1). 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 27 Aug 2026.