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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517746-34 | Other Identifier | EU CTIS number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced breast cancer | Experimental | Patients will receive FKL480 ([68Ga]Ga-DWJ155) |
|
| Advanced NSCLC | Experimental | Patients will receive FKL480 ([68Ga]Ga-DWJ155) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Ga-DWJ155 | Drug | Radioligand imaging agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | Up to 240 minutes after dosing on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Groningen | Provincie Groningen | 9728 | Netherlands |
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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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Imaging study
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The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples. |
| 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 | 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 | 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. | 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. | 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. | Up to 240 minutes after dosing on Day 1 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |