Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Xencor, Inc.
Study ID
NCT06276491
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • XmAb541 — BIOLOGICAL
    Monoclonal bispecific antibody

Study Details

The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.

Key Dates

Start date
Apr 4, 2024
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Dose escalation and Dose Expansion of XmAb541
    Intravenous or Subcutaneous administration

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Day 1 to 2 years ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
StanfordPalo AltoCalifornia94304-
University of CaliforniaSan FranciscoCalifornia94158-
Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
University of Chicago Medical CenterChicagoIllinois60637-
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
Karmanos Cancer InstituteDetroitMichigan48201-
University of MinnesotaMinneapolisMinnesota55455-
The John Theruer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Montefiore Einstein Comprehensive Cancer CenterThe BronxNew York10461-
The Ohio State UniversityColumbusOhio43210-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
SCRI Oncology PartnersNashvilleTennessee37203-
University of VirginiaCharlottesvilleVirginia22903-

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By research site
City of Hope· Duarte, CAStanford· Palo Alto, CAUniversity of California· San Francisco, CAMoffitt Cancer Center· Tampa, FLWinship Cancer Institute, Emory University· Atlanta, GAUniversity of Chicago Medical Center· Chicago, IL

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