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

Novartis

Status and phase: Not yet enrolling; Phase 1

Conditions: Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Treatments: Drug: [68Ga]Ga-DWJ155

Study type: Interventional

Funder types: Industry

Identifiers

NCT07117214

CFKL480A02101

2024-517746-34 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Advanced breast cancer

Experimental group

Description:

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

Treatment:

Drug: [68Ga]Ga-DWJ155

Advanced NSCLC

Experimental group

Description:

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

Treatment:

Drug: [68Ga]Ga-DWJ155