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 being studied for the treatment of breast cancer. It is currently in Phase 1 clinical development, and the ongoing trial also includes patients with non-small cell lung cancer, gastric/gastroesophageal junction cancer, and bladder cancer.
Lu-DWJ155 is a radioligand therapy, but its specific molecular target has not been disclosed. The drug is being studied in a Phase 1 trial that includes a companion diagnostic agent, [68Ga]Ga-DWJ155, which is used for imaging.
Lu-DWJ155 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. The company is conducting a Phase 1 clinical trial of the drug in multiple countries.
Lu-DWJ155 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants.
Lu-DWJ155 is being evaluated in a single Phase 1 clinical trial, identified as NCT07660055. This study is recruiting 156 participants with solid tumors, including breast cancer, and is being conducted in the United States, Australia, Canada, and Japan.
Yes, Lu-DWJ155 is also known as [177Lu]Lu-DWJ155. The drug is a radioligand therapy, and the companion imaging agent used in the trial is [68Ga]Ga-DWJ155.