Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
tebotelimab · 1 trial · 10 indications
Safety 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.
Safety
| Arm | Type | Description |
|---|---|---|
| Tebotelimab: 1 mg | EXPERIMENTAL | - |
| Tebotelimab 3 mg | EXPERIMENTAL | - |
| Tebotelimab: 10 mg | EXPERIMENTAL | - |
| Tebotelimab: 30 mg | EXPERIMENTAL | - |
| Tebotelimab: 120 mg | EXPERIMENTAL | - |
| Tebotelimab: 400 mg | EXPERIMENTAL | - |
| Tebotelimab: 600 mg | EXPERIMENTAL | - |
| Tebotelimab: 800 mg | EXPERIMENTAL | - |
| Tebotelimab: 1200 mg | EXPERIMENTAL | - |
| Combination cohort 1 | EXPERIMENTAL | Tebotelimab and margetuximab |
| Combination Cohort 2 | EXPERIMENTAL | Tebotelimab and margetuximab |
| Monotherapy Cohort Expansion | EXPERIMENTAL | Monotherapy expansion at 600 mg |
| Name | Type | Description |
|---|---|---|
| tebotelimab 1 mg | BIOLOGICAL | 1 mg IV every other week |
| tebotelimab 3 mg | BIOLOGICAL | 3 mg IV every other week |
| tebotelimab 10 mg | BIOLOGICAL | 10 mg IV every other week |
| tebotelimab 30 mg | BIOLOGICAL | 30 mg IV every other week |
| tebotelimab 120 mg | BIOLOGICAL | 120 mg IV every other week |
| tebotelimab 300 mg | BIOLOGICAL | 300 mg IV every other wee |
| tebotelimab 400 mg | BIOLOGICAL | 400 mg IV every other wee |
| tebotelimab 600 mg | BIOLOGICAL | 600 mg IV every other week |
| tebotelimab 800 mg | BIOLOGICAL | 800 mg IV every other week |
| tebotelimab 1200 mg | BIOLOGICAL | 1200 mg IV every other week |
| margetuximab | BIOLOGICAL | 15 mg/kg IV every 3 weeks |
Inclusion Criteria: * Histologically proven, locally advanced unresectable or metastatic solid tumors (or hematologic malignancies, Cohort Expansion only) for whom no approved therapy with demonstrated clinical benefit is available or standard treatment was declined. * Eastern Cooperative Oncology ...
| 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 |
Tebotelimab is an investigational monoclonal antibody being developed by MacroGenics, Inc. for advanced solid tumors and hematologic neoplasms. It is a bispecific antibody that binds PDCD1 and LAG3, and it has been studied in a Phase 1 clinical trial. It is not yet approved for any indication.
Tebotelimab targets PDCD1 (PD-1) and LAG3. It is a bispecific monoclonal antibody designed as an inhibitor of both checkpoint receptors. By binding these two targets, tebotelimab aims to interfere with inhibitory signaling that limits T-cell activity against tumor cells.
Tebotelimab has been studied in advanced solid tumors, including ovarian cancer, HER2-positive solid tumors, non-small cell lung cancer, small-cell lung cancer, squamous cell carcinoma of the head and neck, cholangiocarcinoma, cervical cancer, and triple-negative breast cancer, as well as hematologic neoplasms. It remains investigational.
Tebotelimab is developed by MacroGenics, Inc., which trades under the ticker MGNX. MacroGenics is the sponsor of the clinical program evaluating tebotelimab in advanced solid tumors and hematologic neoplasms.
Tebotelimab is in Phase 1 clinical development. Its single registered trial, NCT03219268, has completed, and the drug is not approved by the FDA for any indication. It remains an investigational agent.
Tebotelimab has been evaluated in one clinical trial, NCT03219268, titled A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms. That Phase 1 trial enrolled 277 patients across the United States, Australia, Bulgaria, Hong Kong, Poland, Spain, Thailand, and Ukraine, and it is now completed.