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RecruitingLast updated: 2 September 2020

AMG 509: This phase I trial is trying to understand how much immunotherapy is safe and effective for the treatment of castration-resistant prostate cancer that has spread to other parts of the bodyA Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Clinical summary

Summary

This is a dose exploration and expansion study. In the dose exploration phase, eligible patients will receive a short term intravenous (IV) infusion of AMG 509 to determine the recommended phase 2 dose (RP2D) or a maximum tolerate dose. In the dose expansion phase of the study, eligible patients will receive the RP2D of AMG 509, administered as a short term IV infusion. Dexamethasone will be administered in both the dose exploration and expansion phase, prior to cycle 1 dosing.

Conditions

This trial is treating patients with castration resistant prostate cancer.

Cancer

Urinary System Cancers Urinary System

Age

People18+

Phase

I

Trial Acronym

AMG 509

More information

Trial Identifiers

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Commercial Sponsor

AMGEN

Scientific Title

A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Eligibility

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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