| Trial ID # | NCT03219268 |
| Phase | I |
| Drug Class | Immunotherapy: Bispecifics/PD-1, LAG-3 |
| Drug Name | Tebotelimab |
| Alternate Drug Names | MGD013, dual-affinity retargeting protein MGD013, anti-PD-1/anti-LAG-3 DART protein MGD013 |
| Drugs in Trial | Margetuximab, Tebotelimab |
| Eligible Participant | Advanced solid tumors |
| Patients Enrolled | Teb expansion: 23 ovarian; Teb+Marg: 41 HER2+; median 2 prior therapies (5 ovarian) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Non-randomized |
| Endpoints | ORR, DCR, evaluated per RECIST |
| Efficacy | ORR: 8.7% (2PR) Tebotelimab (MGD013)+Margituximab: 41 HER2+ patients, median 2 prior therapies, 5 ovarian |
| Conclusion | Tebotelimab has an acceptable safety profile and shows encouraging early evidence of anti-tumor activity |
| Reference | Luke JJ et al. A phase I, first-in-human, open-label, dose-escalation study of MGD013, a bispecific DART molecule binding PD‑1 and LAG‑3, in patients with unresectable or metastatic neoplasms. J Clin Oncol (2020) 38: (suppl; abstr 3004) Luke JJ et al. Slide from presentation Patel M et al. A phase 1 evaluation of tebotelimab, a bispecific PD-1 x LAG-3 DART® molecule, in combination with margetuximab in patients with advanced HER2+ neoplasms. J Immunother Cancer (2020) Vol 8, Suppl. 3, abstract 313 Patel M et al. Poster |