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Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 \[Dose Escalation\]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 \[Dose Expansion\]).
Official title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
279
Start Date
2017-12-16
Completion Date
2027-10-20
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Talquetamab
Participants will receive IV infusion or SC injection of Talquetamab.
Locations (13)
University of Alabama Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Mount Sinai Medical Center
New York, New York, United States
Tennessee Oncology
Nashville, Tennessee, United States
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, Belgium
VU Medisch Centrum
Amsterdam, Netherlands
UMCU
Utrecht, Netherlands
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Hosp Univ Fund Jimenez Diaz
Madrid, Spain
Clinica Univ. de Navarra
Pamplona, Spain
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, Spain
Hosp Clinico Univ de Salamanca
Salamanca, Spain