Phase 1 Study of OTS167 in Patients With Solid Tumors

Inclusion Criteria:

1. Male or female patients, >= 18 years of age at the time of obtaining informed
consent.

2. Patients with a documented (histologically- or cytologically-proven) solid tumor
malignancy that is locally advanced or metastatic.

3. Patients with a malignancy that is either refractory to standard therapy or for which
no standard therapy is available.

4. Patients with a malignancy that is currently not amenable to surgical intervention
due to either medical contraindications or non-resectability of the tumor.

5. Patients with measurable or non-measurable disease according to the response
evaluation criteria in solid tumors (RECIST , v1.1)

6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of
0 or 1.

7. Patients, both male and female, who are either not of childbearing potential or who
agree to use a medically effective method of contraception during the study and for 3
months after the last dose of study drug.

8. Patients with the ability to understand and give written informed consent for
participation in this trial, including all evaluations and procedures as specified by
this protocol.

Exclusion Criteria:

1. Women who are pregnant or lactating. Women of child-bearing potential (WOCBP), and
fertile men with a WOCBP-partner not using adequate birth control.

2. Patients with known central nervous system (CNS) or leptomeningeal metastases not
controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS
involvement for which treatment is required.

3. Patients with any hematologic malignancy. This includes leukemia (any form),
lymphoma, and multiple myeloma.

4. Patients with any of the following hematologic abnormalities at baseline:

- Absolute neutrophil count (ANC) < 1,500 per mm3

- Platelet count < 100,000 per mm3

5. Patients with any of the following serum chemistry abnormalities at baseline:

- Total bilirubin >= 1.5 × the ULN for the institution

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >= 3 × the
upper limit normal (ULN) for the institution (>= 5 × if due to hepatic
involvement by tumor)

- Serum albumin < 2.5 g/dL

- Creatinine >= 1.5 × ULN for the institution (or a calculated creatinine
clearance < 60 mL/min/1.73 m2)

6. Patients with a significant cardiovascular disease or condition, including:

- Congestive heart failure (CHF) currently requiring therapy

- Need for antiarrhythmic medical therapy for a ventricular arrhythmia

- Severe conduction disturbance

- Angina pectoris requiring therapy

- Corrected QT (QTc) interval > 450 msec (males) or > 470 msec (females)

- QTc interval <= 300 msec

- History of congenital long QT syndrome or congenital short QT syndrome

- Left ventricular ejection fraction < 50%

- Uncontrolled hypertension (per the Investigator's discretion)

- Class III or IV cardiovascular disease according to the New York Heart
Association's (NYHA) Functional Criteria.

- Myocardial infarction (MI) within 6 months prior to first study drug
administration

7. Patients with a known or suspected hypersensitivity to any of the components of
OTS167.

8. Patients with a known history of human immunodeficiency virus (HIV) or active
infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

9. Patients with any other serious/active/uncontrolled infection, any infection
requiring parenteral antibiotics, or unexplained fever > 38ºC within 1 week prior to
first study drug administration.

10. Patients with inadequate recovery from acute toxicity associated with any prior
antineoplastic therapy.

11. Patients with inadequate recovery from any prior surgical procedure, or patients
having undergone any major surgical procedure within 4 weeks prior to first study
drug administration.

12. Patients with any other life-threatening illness, significant organ system
dysfunction, or clinically significant laboratory abnormality, which, in the opinion
of the Investigator, would either compromise the patient's safety or interfere with
evaluation of the safety of the study drug.

13. Patients with a psychiatric disorder or altered mental status that would preclude
understanding of the informed consent process and/or completion of the necessary
studies.

14. Patients with the inability or with foreseeable incapacity, in the opinion of the
Investigator, to comply with the protocol requirements.