A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers
- Conditions
- Breast NeoplasmsCarcinoma, Non-Small-Cell Lung
- Interventions
- Drug: [68Ga]Ga-DWJ155
- Registration Number
- NCT07117214
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Advanced breast cancer [68Ga]Ga-DWJ155 Patients will receive FKL480 (\[68Ga\]Ga-DWJ155) Advanced NSCLC [68Ga]Ga-DWJ155 Patients will receive FKL480 (\[68Ga\]Ga-DWJ155)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) 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.
Dosimetry sub-group: Observed maximum concentration (Cmax) of FKL480 based on blood radioactivity data 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.
Dosimetry sub-group: Urinary excretion of FKL480 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.
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 The FKL480 pharmacokinetic analysis will be performed based on blood radioactivity concentration data, obtained by measuring in gamma-counting equipment the blood samples
Dosimetry sub-group: Observed time to reach maximum (Tmax) after single dose administration of FKL480 based on blood radioactivity data 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
Dosimetry sub-group: Absorbed radiation dose in normal tissues and total body 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.
Dosimetry sub-group: Effective dose Up to 240 minutes after dosing on Day 1 Effective dose in selected organs and total body as measured by image quantification.