Recent Updates
Recently added Catalysts

obrindatamab

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

obrindatamab · 1 trial · 1 indication

Phase 1 1
NCT03406949MGD009/MGA012 Combination in Relapsed/Refractory CancerAdvanced Solid Tumors
COMPLETED25 Analytics
PHASE1COMPLETED
MGD009/MGA012 Combination in Relapsed/Refractory Cancer
Advanced Solid TumorsUnlock trial analytics

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 to 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

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about obrindatamab

What is obrindatamab used for?

Obrindatamab is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial setting to assess its safety and potential efficacy in patients with advanced solid tumors.

Who makes obrindatamab?

Obrindatamab 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 drug's potential as a treatment for advanced solid tumors.

What phase is obrindatamab in?

Obrindatamab is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in a completed Phase 1 trial to evaluate its safety and tolerability in patients with advanced solid tumors.

What clinical trials is obrindatamab in?

Obrindatamab has been studied in one clinical trial with the identifier NCT03406949, titled 'MGD009/MGA012 Combination in Relapsed/Refractory Cancer.' This Phase 1 trial, which has been completed, enrolled 25 participants with advanced solid tumors in the United States. The trial was uncontrolled and not randomized or double-blinded.

What does obrindatamab target?

Obrindatamab is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being investigated for its potential role in treating advanced solid tumors, though the exact mechanism of action remains unspecified in the public data.