A Phase 1 Study of AMG 330 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Inclusion criteria:

- Informed consent provided

- 18 years or older

- AML as defined by the WHO Classification persisting or recurring following one or more
treatment courses except promyelocytic leukemia (APML) and except AML secondary to
prior myelodysplastic syndrome. For Germany only: AML as defined by the WHO
Classification either persisting/refractory after at least 2 primary induction courses
(ie, no response after at least 2 prior chemotherapy cycles) or recurring after having
achieved an initial response to chemotherapy except promyelocytic leukemia (APML) and
except AML secondary to prior myelodysplastic syndrome.

- More than 5% blasts in bone marrow

- ECOG Performance Status of ≤ 2

- Adequate renal and hepatic function

Exclusion criteria:

- Active extramedullary AML in testes or central nervous system (CNS)

- Known hypersensitivity to immunoglobulins or to any other component of the IP
formulation

- Prior malignancy (other than in situ cancer) unless treated with curative intent and
without evidence of disease for > 2 years before screening

- Autologous HSCT within six weeks prior to start of AMG 330 treatment

- Allogeneic HSCT within three months prior to start of AMG 330 treatment

- History or evidence of cardiovascular risk

- History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 3
months Infection requiring intravenous antibiotics within 1 week of study enrollment
(day 1)

- Known positiv test for HIV

- Positive for Hepatitis B

- Positive for Hepatitis C or chronic Hepatitis C

- Unresolved toxicities from prior antitumor therapy, defined as not having resolved to
CTCAE, version 4.0 grade 1

- Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy,
retinoid therapy, or investigational agent) within 14 days or 5 half-lives of day 1

- Treatment with systemic immune modulators 2 weeks before enrollment (day 1)

- All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the
subject within the 30 days prior to receiving the first dose of AMG 330

- For subjects in expansion cohort only: Ingestion of any food or drink containing
grapefruit or Seville oranges, or St. John´s wort, within 7 days prior to receiving
the first dose of AMG 330

- Prior treatment with a chimeric antigen receptor T cell (CAR-T) infusion for the
treatment of AML (CD33 or other target)

- Prior participation in an investigational study within 21 days of study day 1

- Major surgery within 28 days of study day 1 with the exception of biopsy and long line
insertion

- White blood cells (WBC) > 15,000 cells/mcL at screening

- History or evidence of any other clinically significant disorder, condition or disease
that, in the opinion of the investigator or Amgen physician, if consulted, would pose
a risk to subject safety or interfere with the study evaluation, procedures or
completion

- Men and women of reproductive potential who are unwilling to practice a highly
effective method(s) of birth control while on study through 1 week (women) or 12 weeks
(men)

- Women who are lactating/breastfeeding or who plan to breastfeed while on sudy through
1 week after receiving the last dose of study drug

- Women with a positive pregnancy test

- Women planning to become pregnant while on study through 1 week after receiving the
last dose of study drug

- Subjects likely to not be available to complete all protocol-required study visits or
procedures, and/or to comply with all required study procedures to the best of the
subject and investigator's knowledge