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Also known as MGD009
obrindatamab · 1 trial · 1 indication
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Maximum Tolerated or Administrated Dose of obrindatamab and retifanlimab
| Arm | Type | Description |
|---|---|---|
| obrindatamab + retifanlimab | EXPERIMENTAL | B7-H3 x CD3 DART protein + anti-PD-1 antibody |
| Name | Type | Description |
|---|---|---|
| obrindatamab | BIOLOGICAL | B7-H3 x CD3 DART protein |
| retifanlimab | BIOLOGICAL | anti-PD-1 antibody |
Inclusion Criteria: * Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the require...
| 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 |
Obrindatamab is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It was evaluated in a Phase 1 clinical trial in patients with relapsed or refractory cancer. It is not an approved therapy and remains in clinical development.
Obrindatamab is being developed by MacroGenics, Inc., a biopharmaceutical company that trades under the ticker symbol MGNX. MacroGenics sponsored the Phase 1 study of obrindatamab in advanced solid tumors.
Obrindatamab is in Phase 1 clinical development. The single Phase 1 trial, NCT03406949, has been completed and enrolled 25 patients with advanced solid tumors. The drug is investigational and has not been approved by the FDA.
Obrindatamab was studied in one Phase 1 clinical trial, NCT03406949, titled MGD009/MGA012 Combination in Relapsed/Refractory Cancer. The trial enrolled 25 adults with advanced solid tumors in the United States and is now completed. It was an uncontrolled, non-randomized study.
Yes, the Phase 1 trial of obrindatamab, NCT03406949, was biomarker selected, meaning enrollment was restricted to patients whose tumors expressed a specific biomarker. The study enrolled 25 adults with advanced solid tumors and has been completed.