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A Phase 1/1b Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI3726 in Subjects With Metastatic Castration Resistant Prostate Cancer Who Have Received Prior Treatment With Abiraterone or Enzalutamide

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Trial Profile

A Phase 1/1b Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI3726 in Subjects With Metastatic Castration Resistant Prostate Cancer Who Have Received Prior Treatment With Abiraterone or Enzalutamide

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Sep 2023

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At a glance

  • Drugs MEDI 3726 (Primary) ; Enzalutamide
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Adverse reactions; First in man
  • Sponsors AstraZeneca; MedImmune

    • Most Recent Events

    • 01 Apr 2021 The protocol was amended to alter the pattern of dose escalation from the ~100% proportional increase used initially to incorporate selected intermediate dose cohorts (0.2 and 0.25 mg/kg)as per result published in Clinical Cancer Research
    • 01 Apr 2021 Results (n= 33 as of data cutoff date-17 January, 2020), "evaluating safety and preliminary efficacy data from the dose-escalation portion of MEDI3726 monotherapy in patients with metastatic castration-resistant prostate cancer published in the Clinical Cancer Research
    • 15 Feb 2020 Results (n=33, as of Sept 27 2019) presented at the 2020 Genitourinary Cancers Symposium.

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