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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Dec 2024

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At a glance

  • Drugs Talquetamab (Primary) ; Talquetamab (Primary) ; Recombinant human serum albumin
  • Indications Multiple myeloma
  • Focus First in man; Registrational; Therapeutic Use
  • Acronyms MonumenTAL-1
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 05 Dec 2024 Planned End Date changed from 8 Jan 2027 to 31 Mar 2027.
    • 20 Nov 2024 According to Johnson & Johnson media release, the company has submitted an application for manufacturing and marketing approval of toarquetamab for relapsed or refractory multiple myeloma. Filing is based on results from the Phase I/II MonumenTAL -1 study2,3 and the Phase I MMY1003 study4.
    • 09 Oct 2024 Planned End Date changed from 31 Dec 2026 to 8 Jan 2027.

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