Safety, PK and Efficacy of AI-061 in Advanced Solid Tumors

Inclusion criteria

• ✓. Patient is greater or 18 years of age on the day of signing the informed consent.
• ✓. All genders. Female subject with pregnancy potential must have a negative pregnancy test.
• ✓. Patient must have a performance status of less than or equal to 1 on the ECOG Performance Scale.
• ✓. Patients must have a histological or cytological diagnosis of solid tumors and have progressive locally advanced or metastatic disease.
• ✓. Measurable disease as determined by RECIST v1.1 (either tumor lesion or lymph node lesion or both): Tumor mass: Must be accurately measurable in at least 1 dimension (longest diameter to be recorded) with a minimum size of: 10 mm by computed tomography (CT) scan (CT scan slide thickness must be less than 5 mm). Or: 20 mm by chest X-ray (if clearly defined and surrounded by aerated lung).
• ✓. Patient must have adequate organ function as indicated by the laboratory values. LDH less than or equal to ULN.
• ✓. Voluntary agreement to participate as evidenced by written informed consent.
• ✓. Female patient: agreement on contraceptive methods.