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Also known as [68Ga]Ga-DWJ155
Ga-DWJ155 · 2 trials · 6 indications
Standardized uptake values (SUVs) will be measured in organs of interest, normal tissues, and tumor lesions based on positron emission tomography (PET) imaging.
Standardized uptake value ratios (SUVr) will be calculated as the ratio of SUV in tumor lesions to SUV in normal organs.
Imaging properties of FKL480 will be evaluated by assessing radiotracer uptake, identified via positron emission tomography (PET) scans. The SUVmean and SUVmax will be calculated and reported with summary statistics.
SUVr will be calculated by dividing the SUV of the lesions by the SUV of the different organs in order to identify the reference organ with the lowest uptake and the respective SUVr (i.e. using SUVmean or SUVmax).
| Arm | Type | Description |
|---|---|---|
| [68Ga]Ga-DWJ155 | EXPERIMENTAL | Single administration of \[68Ga\]Ga-DWJ155 |
| Advanced breast cancer | EXPERIMENTAL | Patients will receive FKL480 (\[68Ga\]Ga-DWJ155) |
| Advanced NSCLC | EXPERIMENTAL | Patients will receive FKL480 (\[68Ga\]Ga-DWJ155) |
| Name | Type | Description |
|---|---|---|
| [68Ga]Ga-DWJ155 | DIAGNOSTIC_TEST | Radioligand imaging agent |
Key Inclusion Criteria: * Age ≥ 18 years old * Presence of at least one extracranial measurable lesion by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients with one of the following indications: * HR+/HER2- aB...
Ga-DWJ155 is an investigational imaging agent being studied in adults with solid tumors, including advanced gastroesophageal adenocarcinoma and breast cancer. It is also written as [68Ga]Ga-DWJ155, reflecting its gallium-68 radiolabel. Novartis AG is developing it, and it is currently in Phase 1 clinical testing.
Ga-DWJ155 is being studied for use in patients with advanced solid tumors, specifically advanced gastroesophageal adenocarcinoma, breast cancer including triple-negative breast cancer, and non-small cell lung cancer. It is an investigational agent in Phase 1 development and has not been approved for any indication.
Novartis AG, which trades under the ticker NVS, is the developer of Ga-DWJ155. The company is running the Phase 1 clinical program for this investigational agent in patients with advanced solid tumors.
Ga-DWJ155 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory authority. The program consists of early-stage studies designed to evaluate the agent in adults with advanced solid tumors.
Ga-DWJ155 is being evaluated in two recruiting Phase 1 trials. NCT07801508 is enrolling 66 adults with solid tumors in Australia and Japan, and NCT07117214 is enrolling 36 adults with breast and lung cancers in the Netherlands. Both studies require participants to be at least 18 years old.
Yes, Ga-DWJ155 and [68Ga]Ga-DWJ155 refer to the same investigational agent. The bracketed form is the radiochemical notation that specifies the gallium-68 isotope used in the compound, while Ga-DWJ155 is the shorter name used in company and trial communications.