A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors

Inclusion Criteria:

• Subjects must meet all the following criteria in order to be included in theresearch study:

1. Subject must be ≥18 years-of-age at the time of signature of the informedconsent form (ICF).

2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

3. Subjects with histologically or cytologically confirmed advanced solid tumorswhich have progressed despite standard therapy(ies), or are intolerant tostandard therapy(ies), or have a tumor for which no standard therapy(ies)exists.

4. Subjects with recurrent/refractory AML according to WHO 2016

5. Subjects with life expectancy ≥3 months.

6. Patients with solid tumor must have at least one measurable lesion as definedby RECIST v1.1.

7. Patients who have sufficient baseline organ function.

Exclusion Criteria:

1. History (≤3 years) of cancer that is histologically distinct from the cancer understudy.

2. Known serious allergy to investigational drug or excipients

3. Active brain or spinal metastases

4. History of pericarditis or Grade ≥2 pericardial effusion

5. History of interstitial lung disease.

6. History of Grade ≥2 active infections within 2 weeks

7. Known human immunodeficiency virus (HIV) infection

8. Seropositive for hepatitis B virus (HBV)

9. Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are notdetectable.

10. Any severe and/or uncontrolled medical conditions

11. History of myocardial infarction, unstable angina pectoris, coronary artery bypassgraft, or cerebrovascular accident

12. Impaired cardiac function or clinically significant cardiac diseases

13. QTcF >470 msec at screening

14. History of medically significant thromboembolic events or bleeding diathesis

15. Unresolved Grade >1 toxicity

16. History of malignant biliary obstruction

17. Pregnant or breast-feeding