MGD009/MGA012 Combination in Relapsed/Refractory Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
MacroGenics
Study ID
NCT03406949
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • obrindatamab — BIOLOGICAL
    B7-H3 x CD3 DART protein
  • retifanlimab — BIOLOGICAL
    anti-PD-1 antibody

Study Details

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.

Key Dates

Start date
Feb 27, 2018
Status verified
May 2022
Primary completion
Apr 27, 2022
Completion
Apr 27, 2022

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: obrindatamab + retifanlimab
    B7-H3 x CD3 DART protein + anti-PD-1 antibody

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.03 [ Time Frame: 30 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
University of Southern CaliforniaLos AngelesCalifornia90033-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-
START (South Texas Accelerated Research Therapeutics) - MidwestGrand RapidsMichigan49546-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Mary Crowley Cancer CenterDallasTexas75251-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Virginia Cancer SpecialistsFairfaxVirginia22031-

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