A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms

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 Tebotelimab, Margetuximab
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)
DCR: 52.2% (2PR, 10SD)

Tebotelimab (MGD013)+Margituximab: 41 HER2+ patients, median 2 prior therapies, 5 ovarian
ORR: 28.6% (1CR - cholangiocarcinoma, 5PR, 2uPR - 1 ovarian); DCR: 50% (1CR, 5PR, 2uPR, 6SD) - responses in PD-L1 low patients

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)
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3004

Luke JJ et al. Slide from presentation
https://www.clearityfoundation.org/wp-content/uploads/2020/06/MGD013-ASCO-2020.pdf

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
https://jitc.bmj.com/content/8/Suppl_3/A340

Patel M et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2020/11/SITC-2020-tebotelimab-margetuximab.pdf

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