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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Tebotelimab is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It is also being evaluated in hematologic neoplasms and several specific cancer types, including ovarian cancer, 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.
Tebotelimab is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol MGNX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy in patients with advanced cancers.
Tebotelimab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of tebotelimab has been completed, and the drug remains under clinical investigation for the treatment of advanced solid tumors and other malignancies.
Tebotelimab has been studied in a Phase 1 clinical trial identified as NCT03219268, titled "A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms." This completed trial enrolled 277 participants across multiple countries, including the United States, Australia, Bulgaria, Hong Kong, Poland, Spain, Thailand, and Ukraine.
Yes, tebotelimab is also known as MGD013. The clinical trial NCT03219268, which evaluated tebotelimab, is titled "A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms," confirming that MGD013 is an alternative name for this investigational monoclonal antibody.