Recruiting PHASE1 Breast Neoplasms

New treatment option for Breast Neoplasms

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

ClinicalTrials.gov ID: NCT07117214

What this study is testing

What is [68Ga]Ga-DWJ155?

[68Ga]Ga-DWJ155 is an investigational medicine, being studied as a potential treatment for breast neoplasms.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 1: an early, usually small safety study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 100

You may be able to join if

  • Age ≥ 18 years old
  • Patients with histologically or cytologically confirmed and documented HR+/HER2- advanced breast cancer (aBC), advanced defined as locoregionally...
  • Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional CT scan.

You likely can't join 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 Other protocol-defined inclusion/exclusion criteria may apply.

The study team makes the final eligibility decision.

Where it's taking place

  • Groningen, Provincie Groningen, Netherlands

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Groningen, Provincie Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.