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Recruiting NCT07117214

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

Phase I Interventional Breast Neoplasms Carcinoma, Non-Small-Cell Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [68Ga]Ga-DWJ155.
Who it may be relevant to
Registry conditions: Breast Neoplasms, Carcinoma, Non-Small-Cell Lung. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug [68Ga]Ga-DWJ155
    Radioligand imaging agent

Primary outcome measures

  • 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]
  • 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]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Netherlands · 1 center
  • Novartis Investigative Site — Groningen

Identifiers

NCT: NCT07117214 · CFKL480A02101 · 2024-517746-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗