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Ga-DWJ155

Phase 1

Breast Neoplasms | Small molecule | Oncology |Novartis AG|Last Updated: Aug 27, 2026

Target and mechanism

ModalitySmall molecule

Also known as [68Ga]Ga-DWJ155

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Ga-DWJ155 · 1 trial · 2 indications

Phase 1 1
NCT07117214A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung CancersBreast Neoplasms
RECRUITING36 Analytics
PHASE1RECRUITING
A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
Breast NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Standard Uptake Value (SUV) mean and max of FKL480 uptake in normal organs and tumor lesions over time
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
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).

Secondary Endpoints

Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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
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
Up to 240 minutes after dosing on Day 1
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Advanced breast cancerEXPERIMENTALPatients will receive FKL480 (\[68Ga\]Ga-DWJ155)
Advanced NSCLCEXPERIMENTALPatients will receive FKL480 (\[68Ga\]Ga-DWJ155)

Interventions

NameTypeDescription
[68Ga]Ga-DWJ155DRUGRadioligand imaging agent
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Eligibility Criteria

Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 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...

Countries:Netherlands
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Recent Changes (Last 90 Days)

LOWAug 27, 2026NCT07117214primaryCompletionDate: changed
LOWAug 27, 2026NCT07117214primaryCompletionDate: changed
LOWJul 7, 2026NCT07117214primaryCompletionDate: changed
LOWJul 7, 2026NCT07117214primaryCompletionDate: changed
MEDIUMJun 9, 2026NCT07117214Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMJun 9, 2026NCT07117214Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMJun 9, 2026NCT07117214Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMJun 9, 2026NCT07117214Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about Ga-DWJ155

What is Ga-DWJ155 used for?

Ga-DWJ155 is an investigational small molecule being studied for use in breast neoplasms. It is currently in Phase 1 clinical development for this indication. The drug is also being evaluated in patients with non-small-cell lung cancer as part of an ongoing clinical trial.

What does Ga-DWJ155 target?

Ga-DWJ155 is a small molecule, but its specific molecular target has not been disclosed in available information. The drug is being studied in oncology, specifically for breast neoplasms and non-small-cell lung cancer, but its mechanism of action is not publicly detailed.

Who makes Ga-DWJ155?

Ga-DWJ155 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is Ga-DWJ155 in?

Ga-DWJ155 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to study the drug in patients with breast and lung cancers.

What clinical trials is Ga-DWJ155 in?

Ga-DWJ155 is being studied in a Phase 1 clinical trial with the identifier NCT07117214. This trial is titled 'A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers' and is currently recruiting participants in the Netherlands. The trial aims to enroll 36 patients.

Is Ga-DWJ155 the same as [68Ga]Ga-DWJ155?

Yes, Ga-DWJ155 is also known as [68Ga]Ga-DWJ155. The two names refer to the same investigational drug. The clinical trial NCT07117214 uses the name [68Ga]Ga-DWJ155 in its official title, while Ga-DWJ155 is the shorter form used in some contexts.