A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)

Part of paid clinical trials in San Diego, California.

Sponsor
Xencor, Inc.
Study ID
NCT03752398
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • XmAb®23104 — BIOLOGICAL
    Monoclonal bispecific antibody
  • Yervoy® (ipilimumab) — BIOLOGICAL
    Monoclonal antibody

Study Details

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.

Key Dates

Start date
May 1, 2019
Status verified
Jul 2024
Primary completion
Feb 15, 2024
Completion
Feb 15, 2024

Study Design

Enrollment
198 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: XmAb®23104 Monotherapy
    XmAb®23104 administered by IV dosing on Days 1 and 15 of each 28-day cycle x 2 cycles
  • Experimental: XmAb®23104 Combination Therapy with Ipilimumab
    XmAb®23104 administered by IV on Days 1 and 15 of each 28-day cycle x 2 cycles + Yervoy® (ipilimumab)

Primary Outcome Measure

Treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 56 Days ]

Locations (18)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterSan DiegoCalifornia92093-
University of Colorado Hospital - Anschutz Cancer PavilionAuroraColorado80045-
Sarah Cannon Research Institute at HealthONEDenverColorado80218-
Florida Cancer SpecialistsSarasotaFlorida34232-
Emory UniversityAtlantaGeorgia30322-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of MichiganAnn ArborMichigan48109-
Washington University School of Medicine Siteman Cancer CenterSt LouisMissouri63110-
Columbia University Medical CenterNew YorkNew York10032-
Duke Cancer InstituteDurhamNorth Carolina27710-
Providence Portland Medical CenterPortlandOregon97213-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Mary Crowley Cancer Research - Medical CityDallasTexas75230-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of Utah, Huntsman Cancer InstituteSalt Lake CityUtah84112-
Emily Couric Clinical Cancer CenterCharlottesvilleVirginia22903-
Seattle Cancer Care AllianceSeattleWashington98109-

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