Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Xencor, Inc.
Study ID
NCT05433142
Phase
PHASE1
Status
Recruiting
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Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

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

Interventions

  • XmAb819 — BIOLOGICAL
    Monoclonal Bispecific Antibody

Study Details

The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).

Key Dates

Start date
Jun 13, 2022
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
307 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation and Expansion
    Dose Escalation will establish the dosing schedule for XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The dosing schedule includes the priming dose, step-up priming dose(s), the minimum safe and biologically active dose. Dose Expansion may administer XmAb819 IV, and XmAb819 SC.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (safety and tolerability of XmAb819) [ Time Frame: 28 days ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
Xencor Investigative SitePhoenixArizona85054-
Xencor Investigative SiteDuarteCalifornia91010-
Xencor Investigative SiteSacramentoCalifornia95817-
Xencor Investigative SiteNew HavenConnecticut06520-
Xencor Investigative SiteJacksonvilleFlorida32224-
Xencor Investigative SiteAtlantaGeorgia30322-
Xencor Investigative SiteChicagoIllinois60611-
Xencor Investigative SiteChicagoIllinois60637-
Xencor Investigative SiteLouisvilleKentucky40207-
Xencor Investigative SiteRochesterMinnesota55905-
Xencor Investigative SiteNew BrunswickNew Jersey088901-
Xencor Investigative SiteNew YorkNew York10032-
Xencor Investigative SiteNew YorkNew York10065-
Xencor Investigative SiteCharlotteNorth Carolina28777-
Xencor Investigative SiteDurhamNorth Carolina27710-
Xencor Investigative SiteCincinnatiOhio45267-
Xencor Investigative SiteColumbusOhio43210-
Xencor Investigative SiteOklahoma CityOklahoma73104-
Xencor Investigative SiteNashvilleTennessee37203-
Xencor Investigative SiteSeattleWashington98109-

Find similar trials in Phoenix, AZ

By research site
Xencor Investigative Site· Phoenix, AZXencor Investigative Site· Duarte, CAXencor Investigative Site· Sacramento, CAXencor Investigative Site· New Haven, CTXencor Investigative Site· Jacksonville, FLXencor Investigative Site· Atlanta, GA

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