A Phase 1/2, 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
Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria * Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2 * Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive preg…
Interventions
- DrugTalquetamab
Talquetamab will be administered SC until disease progression.
Locations (78)
- University of Alabama BirminghamBirmingham, Alabama
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- City of HopeDuarte, California
- Memorial Healthcare SystemHollywood, Florida
- Emory University Winship Cancer InstituteAtlanta, Georgia
- University of ChicagoChicago, Illinois