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)

• 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