Recent Updates
Recently added Catalysts

obrindatamab

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |MacroGenics, Inc.|Last Updated: May 19, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03406949MGD009/MGA012 Combination in Relapsed/Refractory CancerPHASE1 COMPLETED 25Feb 27, 2018Apr 27, 2022May 19, 202210 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03
30 months

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.

MTD/MAD
18 months

Maximum Tolerated or Administrated Dose of obrindatamab and retifanlimab

Secondary Endpoints
AUC
30 months
Cmax
30 months
Tmax
30 months
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
obrindatamab + retifanlimabEXPERIMENTALB7-H3 x CD3 DART protein + anti-PD-1 antibody
Interventions
NameTypeDescription
obrindatamabBIOLOGICALB7-H3 x CD3 DART protein
retifanlimabBIOLOGICALanti-PD-1 antibody
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Histologically-proven, unresectable locally advanced or metastatic solid tumors of any histology that test positive for B7-H3 expression on tumor cells or vasculature for whom no approved therapy with demonstrated clinical benefit is available. For all tumor types, the require...

Countries:United States
Unlock Eligibility Criteria