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

NCT ID: NCT07117214

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2027-01-26

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.

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Advanced breast cancer

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

Group Type: EXPERIMENTAL

[68Ga]Ga-DWJ155

Intervention Type: DRUG

Radioligand imaging agent

Advanced NSCLC

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

Group Type: EXPERIMENTAL

[68Ga]Ga-DWJ155

Intervention Type: DRUG

Radioligand imaging agent

Interventions

[68Ga]Ga-DWJ155

Radioligand imaging agent

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Novartis Pharmaceuticals

Role: CONTACT

novartis.email@novartis.com

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

2024-517746-34

Identifier Type: OTHER

Identifier Source: secondary_id

CFKL480A02101

Identifier Type: -

Identifier Source: org_study_id