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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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
89Zr-DFO-REGN5054 is an investigational imaging agent developed by Regeneron Pharmaceuticals for use in immunoPET imaging. It is being studied in adults with advanced or metastatic solid tumors who are being treated with cemiplimab, to visualize treatment-related biology in the body. It is in Phase 1 clinical development.
89Zr-DFO-REGN5054 is being studied as an immunoPET imaging agent in adults with advanced or metastatic solid tumors who are receiving cemiplimab. The Phase 1 study evaluates its use for imaging in this patient population. It is investigational and is not an approved therapy.
89Zr-DFO-REGN5054 is being developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical program evaluating this imaging agent in solid tumors.
89Zr-DFO-REGN5054 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 study is currently active and not recruiting, with a planned enrollment of 22 participants.
89Zr-DFO-REGN5054 is being studied in one Phase 1 trial, NCT05259709, titled a study of immunoPET imaging using 89Zr-DFO-REGN5054 in adult participants with solid cancers treated with cemiplimab. The trial enrolls adults aged 18 and older in the Netherlands and has a planned enrollment of 22.