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Mitoguazone

B7-H3 x CD3 DART protein + anti-PD-1 antibody

obrindatamab

retifanlimab

Stephen L Eck, M.D.

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of obrindatamab administered in combination with retifanlimab in patients with B7-H3- expressing tumors.

This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, PK, pharmacodynamics, immunogenicity, and preliminary antitumor activity of the combination of obrindatamab and retifanlimab, each of which is administered by IV infusion. The study consists of a Dose Escalation Phase to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) (if no MTD is defined) of the combination, followed by a Cohort Expansion Phase to further define the safety and initial antitumor activity of the combination with the doses established in the Dose Escalation Phase. Patients with B7-H3-expressing unresectable, locally advanced, or metastatic solid tumors of any histology will be enrolled in the Dose Escalation Phase. Following the establishment of an MTD, additional patients with specific tumor types will enroll in the Cohort Expansion Phase.

3+3+3 dose escalation design followed by Cohort Expansion Phase.

MGD009/MGA012 Combination in Relapsed/Refractory Cancer

A Phase 1, Open Label, Dose Escalation Study of MGD009, a Humanized B7-H3 x CD3 DART® Protein, in Combination With MGA012, an Anti-PD-1 Antibody, in Patients With Relapsed or Refractory B7-H3-Expressing Tumors

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.

Maximum Tolerated or Administrated Dose of obrindatamab and retifanlimab

Area Under the Plasma Concentration versus Time Curve of obrindatamab and retifanlimab

Maximum Plasma Concentration of obrindatamab and retifanlimab

Time to reach maximum (peak) plasma concentration of obrindatamab and retifanlimab

Trough plasma concentration of obrindatamab and retifanlimab

Total body clearance of the drug from plasma of obrindatamab and retifanlimab

Apparent volume of distribution at steady state of obrindatamab and retifanlimab

Terminal half life of obrindatamab and retifanlimab

Percent of patients with anti-drug antibody to obrindatamab and retifanlimab

Conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRECIST)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MGD009/MGA012 Combination in Relapsed/Refractory Cancer	NCT03406949	Advanced Solid ...	obrindatamab retifanlimab	18 Years -	MacroGenics
MGD009/MGA012 Combination in Relapsed/Refractory Cancer	NCT03406949	Advanced Solid ...	obrindatamab retifanlimab	18 Years -	MacroGenics

Spots Global Cancer Trial Database for obrindatamab

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