Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Active, not recruiting
• Trial end date: 2022-03-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria

• 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 WHO Classification (Appendix D) 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, Appendix F) Performance Status of ≤ 2.

Exclusion Criteria

• Known hypersensitivity to immunoglobulins.

• Autologous 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.