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RecruitingPhase 1NCT07117214

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

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

Sponsor

Novartis Pharmaceuticals

Enrollment

36 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Breast NeoplasmsCarcinoma, Non-Small Cell Lung

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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

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Interventions

DRUG[68Ga]Ga-DWJ155

Radioligand imaging agent

Locations(1)

Novartis Investigative Site

Groningen, Netherlands

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NCT07117214

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