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CompletedLast updated: 5 February 2024

AMG404: This Phase I trial is evaluating how safe and tolerable a combination of targeted therapies (Blinatumomab and AMG 404) is in adults with relapsed or refractory B Cell precursor Acute Lymphoblastic LeukaemiaA Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)

Clinical summary

Summary

This trial has one experimental arm. All participants will receive Blinatumomab (administered as a continuous intravenous infusion) and AMG 404 (administered as an intravenous infusion). Participants will also be administered Dexamethasone (orally or intravenously) prior to blinatumomab treatment as needed.

Conditions

This trial is treating patients with acute lymphoblastic leukaemia.

Cancer

Blood Cancers Haematological

Age

People18 - 99

Phase

I

Trial Acronym

AMG404

More information

Trial Identifiers

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Trial sponsor

AMGEN

Scientific Title

A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)

Eligibility

Inclusion

  • Age ≥ 18 years at enrollment.
  • Greater than or equal to 5% blasts in the bone marrow.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 2.
  • Negative pregnancy test in women of childbearing potential.

Exclusion

  • Cancer chemotherapy (radiotherapy, chemotherapy, antibody therapy, molecular targeted therapy) within 14 days prior to study Day 1.
  • Known hypersensitivity to blinatumomab or AMG 404 or to any component of the product formulation.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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Participating hospitals

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Completed hospitals

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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