NCT07117214RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 22 Jul 2025
- Start date
- 26 Jun 2026
- Primary completion date
- 26 Jan 2029
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Lung cancer, Metastatic breast cancer
- NCT number
- NCT07117214
- EudraCT number
- 2024-517746-34
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 26 Jun 2026 to the primary completion date, 26 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Patients having out of range laboratory values for kidney function and blood markers as defined in the study protocol
Other
- Patients with inadequate hepatic function
- Unmanageable urinary tract obstruction or urinary incontinence
- Other protocol-defined inclusion/exclusion criteria may apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.