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CompletedLast updated: 7 February 2024

This early Phase I trial is evaluating a new drug (AMG 673), administered intravenously to patients with Acute Myeloid Leukaemia (AML) that has got worse or come back following prior therapyA Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 673 Administered as Short Term Intravenous Infusions in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Clinical summary

Summary

This is a first-in-human, open-label, phase 1, sequential dose escalation study. AMG 673 will be evaluated as a short term intravenous (IV) infusion in adult subjects with relapsed/refractory AML. The study will be conducted at approximately 7 sites in the United States, Australia and Germany and will be conducted across two phases - an exploration phase and an expansion phase.

Conditions

This trial is treating patients with Acute Myeloid Leukaemia (AML).

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

AMGEN

Scientific Title

A Phase 1 First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 673 Administered as Short Term Intravenous Infusions in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Eligibility

Inclusion

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
  • Subjects ≥ 18 years of age at the time of signing consent.

  • AML as defined by the World Health Organisation (WHO) Classification persisting or recurring following 1 or more treatment courses except promyelocytic leukemia (APML).

    • More than 5% myeloblasts in bone marrow.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

Exclusion

  • Known hypersensitivity to immunoglobulins.
  • Autologous hematopoietic stem cell transplantation (HSCT) within 6 weeks prior to start of AMG 673 treatment.
  • Allogeneic HSCT within 3 months prior to start of AMG 673 treatment.
  • Non-manageable graft versus host disease.
  • Known positive test for human immunodeficiency virus (HIV).
  • Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 15 weeks after receiving the last dose of study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women). Males who are unwilling to abstain from sperm donation while on study through 5 half-lives after receiving the (last [multiple-dose studies]) dose of study drug.
  • Females who are lactating/breastfeeding or who plan to breastfeed while on study through 15 weeks after receiving the last dose of study drug.
  • Females with a positive pregnancy test
  • Females planning to become pregnant while on study through 15 weeks after receiving the last dose of study drug.

Inclusion

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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • 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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