Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma

Official Title

A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With Relapsed / Refractory Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma

Summary:

Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose [RP2D])

Trial Description

Primary Outcome:

  • Incidence of dose limiting toxicities (DLTs)
  • Incidence of treatment-emergent adverse events
  • Incidence of treatment-related adverse events
  • Incidence of disease-related events
  • Incidence of clinically-significant changes in vital signs
  • Incidence of clinically-significant changes in physical examinations
  • Incidence of clinically-significant changes in electrocardiograms (ECG)s
  • Incidence of clinically-significant changes in clinical laboratory tests
Secondary Outcome:
  • Maximum observed concentration (Cmax) of AMG 562
  • minimum concentration (Cmin)
  • time of maximum concentration (Tmax)
  • area under the concentration-time curve (AUC)
  • Half Life (t1/2)
  • Efficacy-Overall Response
  • Efficacy-Objective Response Rate (ORR)
  • Efficacy-Duration of Response (DOR)
  • Efficacy-Progression Free Survival (PFS)
  • Efficacy-Overall Survival (OS)

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