Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-DWJ155 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Advanced breast cancer
- description
- Patients will receive FKL480 (\[68Ga\]Ga-DWJ155)
- interventionNames
- Drug: [68Ga]Ga-DWJ155
- type
- EXPERIMENTAL
- label
- Advanced NSCLC
- description
- Patients will receive FKL480 (\[68Ga\]Ga-DWJ155)
- interventionNames
- Drug: [68Ga]Ga-DWJ155
Primary outcomes (2)
- measure
- Standard Uptake Value (SUV) mean and max of FKL480 uptake in normal organs and tumor lesions over time
- timeFrame
- Up to 240 minutes after dosing on Day 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available