A Study of ONO-7475 in Patients With Acute Leukemias

Inclusion Criteria:

1. Patients aged ≥18 years at time of screening

2. Written informed consent by the patient (or legal representative) prior to admission
to this study. In addition any locally required authorization (Health Insurance
Portability and Accountability Act in the USA [HIPAA], obtained from the patient prior
to performing any protocol-related procedures, including screening evaluations.

3. Adequate renal and hepatic function defined as:

- Total bilirubin within 1.5 x ULN, except those with Gilberts syndrome for whom
this must be <3 x ULN

- AST(SGOT) and ALT(SGPT) <2.5 x ULN

- Calculated Creatinine clearance>/= 45ml/min

- Serum Albumin >2.5g/dL For any patient laboratory values outside the ranges
outlined above that are considered due to the patient's underlying disease (AML
or ALL), the patient may be enrolled into the study following consultation
between the Investigator and the Sponsor's Medical Officer if the patient is
likely to benefit from receiving ONO-7475 (based on the Investigator's
assessment)

4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 as assessed during
the screening period and then again anytime during the 2-day period immediately
preceding the start of ONO-7475 dosing.

5. Life expectancy of at least 3 months

6. Sexually active female patients of childbearing potential and sexually active male
patients must agree to use an effective method of birth control (e.g., barrier methods
with spermicides, oral or parenteral contraceptives and/or intrauterine devices)
during the entire duration of the study and for 4 months after final administration of
study drug. Note that sterility in female patients must be confirmed in the patients'
medical records and be defined as any of the following: surgical hysterectomy with
bilateral oophorectomy, bilateral tubular ligation, natural menopause with last menses
>1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy
induced menopause with last menses >1 year ago.

7. Male patients must use a condom from the time of the first administration of ONO-7475
until 4 months following administration of the last dose.

8. Diagnosis of AML according to WHO criteria 2016.

9. Relapsed or refractory AML patients with at least 5% blasts by bone marrow biopsy or
aspirate, or at least 1% blasts in peripheral blood, not likely to benefit from standard
salvage chemotherapy.

10. All patients must have received at least one prior therapy - 1 cycle of cytarabine
containing regimen or 2 cycles of hypomethylating agent - before determination of
refractory status (defined as response duration less than 3 months or no response)

Exclusion Criteria:

1. Patients with active Central Nervous System (CNSL) Leukemia

2. QTcF prolongation defined as a QTcF interval >470 msec or other significant ECG
abnormalities including 2nd degree (type II) or 3rd degree AV block or bradycardia
(ventricular rate <50 beats/min).

3. Clinically significant liver disease, including active viral or other hepatitis,
current alcohol abuse, or severe cirrhosis

4. HIV/active Hepatitis B or C infection

5. Retinal disease (e.g. retinitis pigmentosa including Mertk mutations), retinal
hemorrhage or any disorder which may inhibit follow up for retinal toxicity

6. Serious intercurrent medical or psychiatric illness that will prevent participation or
compliance with study procedures, including serious active infection

7. Acute promyelocytic leukemia (FAB M3 classification)

8. Patients not recovered to Grade 1 or stabilized from the effects (excluding alopecia)
of any prior therapy for their malignancies

9. Concurrent treatment with other investigational drugs.

10. Daily requirement for corticosteroids ≥ prednisone 10 mg/day or equivalent.

11. Prior hematopoietic stem cell transplantation within 12 weeks of the first dose of
study treatment or ongoing immunosuppressive therapy for graft versus host disease

12. Participation in another clinical trial with any investigational drug within 14 days
or with any licensed drug within five half-lives, prior to the first ONO-7475 dosing.

13. Prior AML or ALL therapy (non-experimental) within 14 days or five half-lives
whichever is longer, prior to the first dose of ONO-7475 (except those permitted in
the protocol) and no residual toxicity from the prior therapy hindering of the
ONO-7475 dosing.

14. Prior radiotherapy within 21 days of screening. Localized radiation therapy within the
last 7 days is acceptable. Concurrent radiotherapy is not permitted.

15. Patients undergoing current treatments for other cancers

16. Pregnant or lactating women

17. Proliferative disease (WBC > 30 x 109 /L) confirmed prior to first dose of ONO-7475

18. Active malignancy, other than AML (Parts A and B) or ALL (Part C), requiring systemic
therapy