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NCT Number: NCT07117214

A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers

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.

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Key information

Conditions

Breast Neoplasms Adenocarcinoma Breast Diseases Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Groningen, Provincie Groningen, 9728, Netherlands

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Exclusion criteria

  • 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.

Treatment and study plan

[68Ga]Ga-DWJ155

Drug

Radioligand imaging agent

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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

    Incidence and severity of AEs and SAEs, including changes in vital signs and laboratory values qualifying and reported as AEs.

  2. 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

    The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples.

  3. 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

    The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples

  4. 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

    The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples

  5. Dosimetry sub-group: Urinary excretion of FKL480

    Time frame: Up to 240 minutes after dosing on Day 1

    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.

  6. Dosimetry sub-group: Absorbed radiation dose in normal tissues and total body

    Time frame: Up to 240 minutes after dosing on Day 1

    Absorbed radiation dose coefficients in selected organs and lesions and total body as measured by image quantification.

  7. Dosimetry sub-group: Effective dose

    Time frame: Up to 240 minutes after dosing on Day 1

    Effective dose in selected organs and total body as measured by image quantification.

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 12, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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