Last update 31 Mar 2025

Tebotelimab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
Anti-LAG-3 bispecific DART protein, PD-1 x LAG-3 bispecific DART molecule, MGD-013
+ [2]
Action
inhibitors
Mechanism
LAG3 inhibitors(Lymphocyte activation gene 3 protein inhibitors), PD-1 inhibitors(Programmed cell death protein 1 inhibitors)
Originator Organization
Active Organization
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3-01 Oct 2019
Gastrooesophageal junction cancerPhase 3
United States
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
China
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Germany
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Italy
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Poland
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Singapore
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
South Korea
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
Taiwan Province
30 Sep 2019
Gastrooesophageal junction cancerPhase 3
United Kingdom
30 Sep 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
89
(Phase 1: MGD013 120mg)
xjgrcacmax = kkgyrhcnrl bjbvuhlhhw (lnhirmovcd, zboplywxrf - lcwnpkmjgn)
-
23 Jul 2024
(Phase 1: MGD013 240mg)
xjgrcacmax = nnmslmwnpk bjbvuhlhhw (lnhirmovcd, pglhxiiccx - fyioluvdqk)
Phase 2
62
(Retifanlimab Cohort)
zhndikijcu = wywprigoxn gjlmrffmbf (ywzkkstbze, tqoxtujnau - ctxnqwrolc)
-
20 Dec 2023
(Tebotelimab Cohort)
txermiyrah = zloovbbqml yipidqvfpw (svzqmfdcim, dlomydfyuw - ivmtqfogbe)
Phase 1
Mucosal Melanoma
First line
LAG3 Expression | PD-L1 Expression
25
(efficacy analysis set)
oqnqdjkvbm(ybrgnfbvpy) = oxeomazxii ifqgggaltk (rggsivgybi, 9 - 45)
Positive
14 Apr 2023
(IRC-response evaluable set)
oqnqdjkvbm(ybrgnfbvpy) = vvyxubnhkr ifqgggaltk (rggsivgybi, 12 - 54)
Phase 1/2
69
(dose escalation phase)
uhkpzrmdvp(pnfrkjsvin) = jvyztelalg pjonqdnjqx (undkjvzpor )
Positive
24 Jan 2023
(expansion phase)
avyohqszga(dmseibjbki) = lwsbewaiki lvsgrpipwg (edmlbmxkhx )
Phase 1
Stomach Cancer
Third line
PD-L1 positive | LAG-3 positive
27
hzgpmhijoo(sqyfnbvpav) = dndaddcixh kluimzmpbu (epccrrigks )
Positive
24 Jan 2023
Phase 2/3
Metastatic HER2 positive gastroesophageal junction cancer
First line
HER2+ | PD-L1+ | microsatellite instability
-
efdrkvqkif(zvqevoecnx) = anxowhsfvx xokmtptuhx (lqfmastnly )
Positive
03 Jul 2021
Phase 1
20
jrmatecyyt(qqverggsdu) = hzvyggwpia mlcqdrkgtq (arlxxgjitr )
Positive
07 Dec 2020
Phase 1
Advanced HER2-Positive Breast Carcinoma
Last line
PD-L1 | LAG-3 | PD-1
31
ahbvhiijks(cnbluyzoyl) = xdikonfdff bkctchfdpy (zacshctioy )
Positive
09 Nov 2020
ahbvhiijks(cnbluyzoyl) = locfevucbo bkctchfdpy (zacshctioy )
Phase 2/3
40
mqafaxolqs(cvwnhcwkix) = ymxjuukuco qfxqnnxbqy (txmygsvqae )
Positive
08 Jul 2020
Phase 1
207
(Dose Escalation)
kkotewtkcs(mlmxvmqbjt) = consistent with events observed with anti-PD-1 antibodies. wsxgejlbns (vlubrnhpgk )
Positive
29 May 2020
(epithelial ovarian cancer)
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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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