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89Zr˗DFO˗REGN5054 · 1 trial · 2 indications
Part A
Part A and B
| Arm | Type | Description |
|---|---|---|
| Single ascending dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab | EXPERIMENTAL | Part A: Doses of 89Zr˗DFO˗REGN5054 may be reduced based upon assessment. |
| Defined dose of 89Zr˗DFO˗REGN5054 followed by fixed dose of cemiplimab | EXPERIMENTAL | Part B: Defined dose of 89Zr˗DFO˗REGN5054 determined in Part A. |
| Name | Type | Description |
|---|---|---|
| 89Zr˗DFO˗REGN5054 | DRUG | Administered by intravenous (IV) infusion during Part A and B. |
| cemiplimab | DRUG | Administered by IV infusion every 3 weeks (Q3W). |
Key Inclusion Criteria: * Advanced or metastatic solid tumors that may respond to anti-programmed cell death 1 (PD-1) immunotherapy * Measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status of...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
89Zr-DFO-REGN5054 is an investigational imaging agent developed by Regeneron Pharmaceuticals, Inc. (ticker: REGN). It is being studied in a Phase 1 trial for ImmunoPet imaging in adult participants with advanced or metastatic solid tumors who are being treated with cemiplimab. It is not a therapeutic drug; it is used to visualize targets in the body.
89Zr-DFO-REGN5054 is used for ImmunoPet imaging in adult participants with advanced or metastatic solid tumors who are receiving cemiplimab. The Phase 1 study is evaluating its use as an imaging agent, not as a treatment. It is designed to help visualize specific targets in tumors.
89Zr-DFO-REGN5054 is being developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is the sponsor of the Phase 1 trial evaluating this imaging agent in patients with solid cancers treated with cemiplimab.
89Zr-DFO-REGN5054 is in Phase 1 clinical development. The only trial is a Phase 1 study that is currently recruiting participants. It is an investigational agent and has not been approved by the FDA for any indication.
89Zr-DFO-REGN5054 is being studied in one clinical trial: NCT05259709, titled "A Study of ImmunoPet Imaging Using 89Zr-DFO-REGN5054 in Adult Participants With Solid Cancers Treated With Cemiplimab." This Phase 1 trial is recruiting up to 50 participants in the Netherlands.
No, 89Zr-DFO-REGN5054 is not FDA approved. It is an investigational imaging agent in Phase 1 clinical development. The ongoing trial, NCT05259709, is evaluating its use in adult participants with advanced or metastatic solid tumors who are being treated with cemiplimab.