Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With mCRPC

Official Title

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager AMG 160 in Subjects With Metastatic Castration-resistant Prostate Cancer

Summary:

A study to evaluate the safety and tolerability of AMG 160 and in combination with pembrolizumab in adult subjects with metastatic castration-resistant prostate cancer (mCRPC), and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Trial Description

Primary Outcome:

  • Number of participants with dose-limiting toxicity
  • Number of participants with treatment-emergent adverse events
  • Number of participants with treatment-related adverse events
  • Number of participants with clinically significant changes in vital signs
  • Number of participants with clinically significant changes in electrocardiogram (ECG)
  • Number of participants with clinically significant changes in clinical laboratory tests
Secondary Outcome:
  • Subject incidence of changes in pharmacokinetics - maximum serum concentration (Cmax)
  • Objective response (OR)
  • Prostate-specific antigen (PSA) response
  • Duration of response (DOR) (radiographic and PSA)
  • Change in time to progression (radiographic and PSA)
  • 1, 2 and 3-year overall survival (OS)
  • Other PCWG3-recommended endpoints - time to symptomatic skeletal events
  • Subject incidence of changes in pharmacokinetics - minimum serum concentration (Cmin)
  • Subject incidence of changes in pharmacokinetics - area under the concentration-time curve (AUC) over the dosing interval
  • Subject incidence of changes in pharmacokinetics - administration including accumulation following multiple dosing
  • Subject incidence of changes in pharmacokinetics - half-life
  • Other PCWG3-recommended endpoints - lactate dehydrogenase [LDH]
  • Other PCWG3-recommended endpoints - hemoglobin
  • Other PCWG3-recommended endpoints - neutrophil-to-lymphocyte ratio
  • Other PCWG3-recommended endpoints - urine N-telopeptide
  • Other PCWG3-recommended endpoints alkaline phosphatase [total, bone]
This is a phase I, first-in-human study to evaluate the safety and tolerability of AMG 160; a half-life extended (HLE) bispecific T-cell engager (BiTE®) antibody construct, alone and in combination with pembrolizumab in subjects with metastatic castration-resistant prostate cancer.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society