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

NCT07117214 | Recruiting Phase 1

• 2 other identifiers: CFKL480A021012024-517746-34
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Keywords

Breast cancer; Non-small cell lung cancer; Radioligand imaging; [68Ga]Ga-DWJ155; FKL480; gallium; adenocarcinoma; ductal; lobular; positron emission tomography (PET); dosimetry

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• 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

• 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

• Dosimetry sub-group: Urinary excretion of FKL480

  Up to 240 minutes after dosing on Day 1

Study Arms (2)

Advanced breast cancer

EXPERIMENTAL

Patients will receive FKL480 (\[68Ga\]Ga-DWJ155)

Drug: [68Ga]Ga-DWJ155

Advanced NSCLC

EXPERIMENTAL

Patients will receive FKL480 (\[68Ga\]Ga-DWJ155)

Drug: [68Ga]Ga-DWJ155

Interventions

[68Ga]Ga-DWJ155 DRUG

Radioligand imaging agent

Advanced NSCLC; Advanced breast cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Groningen, Provincie Groningen, 9728, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Imaging study

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 12, 2025
• Study Start: June 26, 2026
• Primary Completion (Estimated): December 11, 2028
• Study Completion (Estimated): December 11, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)