Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [177Lu]Lu-DWJ155
Lu-DWJ155 · 1 trial · 4 indications
Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, echocardiograms (ECGs), and imaging assessments qualifying and reported as AEs.
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness/injury or concomitant medications that occurs within the first treatment cycle. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Number of participants with dose interruptions and/or reductions to assess the tolerability.
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Patients will receive \[68Ga\]Ga-DWJ155 and, if eligible, \[177Lu\]Lu-DWJ155. In this part, multiple dose levels of \[177Lu\]Lu-DWJ155 will be evaluated. |
| Dose Expansion | EXPERIMENTAL | Patients will receive \[68Ga\]Ga-DWJ155 and, if eligible, \[177Lu\]Lu-DWJ155 at the recommended dose established during the dose escalation part. |
| Name | Type | Description |
|---|---|---|
| [68Ga]Ga-DWJ155 | DIAGNOSTIC_TEST | Radioligand imaging agent |
| [177Lu]Lu-DWJ155 | DRUG | Radioligand therapy |
Inclusion Criteria: * Male or female patients age ≥ 18 years. * Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of care therapy, and are not considered appropriate for any standard therapy...
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Lu-DWJ155 is an investigational small molecule radiopharmaceutical being developed by Novartis AG for the treatment of solid tumors, including breast cancer. It is in Phase 1 clinical development and is also known as [177Lu]Lu-DWJ155. It has not been approved by the FDA.
Lu-DWJ155 is being studied in breast cancer as part of a Phase 1 trial that also enrolls patients with non-small cell lung cancer, gastric or gastroesophageal junction cancer, and bladder cancer. It is investigational and has not been approved for any indication.
Lu-DWJ155 is developed by Novartis AG, which trades under the ticker NVS. Novartis is running the clinical program for this radiopharmaceutical candidate across multiple solid tumor types.
Lu-DWJ155 is in Phase 1 clinical development. It is an investigational agent and is not FDA approved. The single Phase 1 study is currently recruiting participants and has an enrollment target of 156 patients.
Lu-DWJ155 is being evaluated in one active Phase 1 trial, NCT07660055, titled Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors. The trial is recruiting in the United States, Australia, Canada, and Japan and has an enrollment target of 156 adults.
Yes, [177Lu]Lu-DWJ155 is an alternative name for Lu-DWJ155. Both names refer to the same investigational Novartis radiopharmaceutical in Phase 1 development for solid tumors, including breast cancer.