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Also known as [89Zr]DFO-YS5
DFO-YS5 · 1 trial · 12 indications
A volume of interest (VOI) will be placed around each lesion, and the calculated maximum standard uptake value (SUVmax) will be recorded for each lesion. Adjusted SUVmax data will then be averaged across up to 15 lesions within a given patient (SUVmax-avg) at each time point. In order to avoid clustering effects, analyses will be limited to the five largest osseous metastases, five largest lymph node metastases, and five largest visceral/soft tissue metastases. Metastatic lesion location, size (bidimensional axial measurement), and SUVmax will be tabulated. This will be conducted for all lesions.
The median and range for intra-tumoral SUVmax within metastatic lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.
The tumor-to-background signal refers to comparing the standardized uptake value (SUV) of a lesion (tumor) to the SUV of a nearby normal organ or tissue that serves as a "background" reference. The ratio of the tumor-to-background signal on PET scan (normal organ as background uptake values) will be calculated as the SUVmax of tumor divided by the SUV of background organ
| Arm | Type | Description |
|---|---|---|
| Treatment ([89Zr]DFO-YS5) | EXPERIMENTAL | Participants will be administered a single, intravenous microdose (1.0 - 3.0 mCi) of \[89Zr\]DFO-YS5, followed by whole-body positron emission tomography (PET) imaging conducted 120-168 hours after \[89Zr\]DFO-YS5 administration (i.e., on Day 6-8). Participants will be followed for treatment-emergent adverse events for up to 35 days. |
| Name | Type | Description |
|---|---|---|
| [89Zr]DFO-YS5 | DRUG | Given intravenously (IV) |
| Positron Emission Tomography (PET)-Computerized tomography (CT) | PROCEDURE | Participants may receive a whole-body PET-CT or a whole-body PET-MRI |
Inclusion Criteria: 1. Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm. 2. At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography ...
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DFO-YS5 is an investigational small molecule imaging agent being developed by Kyntra Bio, Inc. for cancer detection. It is also known as [89Zr]DFO-YS5. The compound is in Phase 1 clinical development and is being studied in bladder cancer and other solid tumor malignancies.
DFO-YS5 is being studied as an imaging agent for cancer detection in bladder cancer. It is designed to help visualize tumors rather than to treat them. The Phase 1 imaging study is enrolling adults with bladder cancer and other solid tumors to evaluate how well the agent detects disease.
Kyntra Bio, Inc. is developing DFO-YS5. The company trades under the ticker KYNB. Kyntra Bio is the sponsor of the ongoing Phase 1 imaging study of [89Zr]DFO-YS5 in bladder cancer and other solid tumor malignancies.
DFO-YS5 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The single Phase 1 trial is currently recruiting participants, and no trials of DFO-YS5 have been completed to date.
DFO-YS5 is being evaluated in one active clinical trial, NCT07664397, titled Imaging Study of [89Zr]DFO-YS5 for Cancer Detection. The Phase 1 study is recruiting and plans to enroll 40 participants aged 18 years and older in the United States. It is an uncontrolled, non-randomized study.
Yes, DFO-YS5 and [89Zr]DFO-YS5 refer to the same investigational imaging agent. The bracketed form reflects the zirconium-89 radiolabel used in the compound. Both names appear in connection with the Phase 1 cancer detection study sponsored by Kyntra Bio, Inc.