A Dose Finding Study of CC-96673 in Participants With Relapsed or Refractory Non-Hodgkin's Lymphoma

Official Title

A Phase 1, Multicentre, Open-label, Dose Finding Study of CC-96673 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

Summary:

The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL). The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

Trial Description

Primary Outcome:

  • Incidence of Adverse Events (AEs)
  • Dose-limiting toxicity (DLT)
  • Maximum tolerated dose (MTD)
Secondary Outcome:
  • Overall response rate (ORR)
  • Time to response (TTR)
  • Duration of response (DOR)
  • Progression free survival (PFS)
  • Pharmacokinetics - Cmax
  • Pharmacokinetics - Cmin
  • Pharmacokinetics - AUC
  • Pharmacokinetics - tmax
  • Pharmacokinetics - t1/2
  • Pharmacokinetics - CL
  • Pharmacokinetics - Vss
  • Pharmacokinetics - Accumulation ratio
  • Presence of Anti-drug antibodies (ADA)
  • Frequency of Anti-drug antibodies (ADA)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society