Study to Evaluate the Safety and Tolerability of CC-92328 in Participants With Relapsed and/or Refractory Multiple Myeloma

Titre officiel

A Phase 1, Multi-centre, Open-label, Dose Finding Study of CC-92328 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Sommaire:

This Phase 1, first-in-human (FIH), clinical study of CC-92328 will explore the safety, tolerability and preliminary biological and clinical activity of CC-92328 as a single-agent in the setting of relapsed and/or refractory multiple myeloma (R/R MM). The study will be conducted in two parts: monotherapy dose escalation (Part A) and monotherapy dose expansion (Part B).

Description de l'essai

Primary Outcome:

  • Dose-Limiting Toxicities (DLTs)
  • Maximum Tolerated Dose (MTD)
  • Incidence of Adverse Events (AEs)
Secondary Outcome:
  • Preliminary Efficacy - Overall Response Rate (ORR)
  • Preliminary Efficacy - Time to response
  • Preliminary Efficacy - Duration of response
  • Preliminary Efficacy - Progression-free Survival (PFS)
  • Preliminary Efficacy - Overall Survival (OS)
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - Cmin
  • Pharmacokinetics - AUC
  • Pharmacokinetics - tmax
  • Pharmacokinetics - t1/2
  • Pharmacokinetics - CL
  • Pharmacokinetics - Vd
  • Pharmacokinetics - Accumulation index of CC-92328
  • Presence of Anti-CC92328 antibodies (ADA)
  • Frequency of Anti-CC92328 antibodies (ADA)

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer