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

Prior treatment

• Patients who have not recovered to NCI CTCAE v5.0 less than or equal toGrade 1 from an adverse event (AE) due to cancer therapeutics except endocrinopathy or the chemotherapy-associated peripheral neuropathy (motor or sensory) that has recovered to CTCAE v5.0 less than or equal to Grade 2 will be allowed. The washout period for cancer therapeutic drugs should be 21 days prior to the first AI-061 dose for chemotherapy, radiation, or targeted therapy or 28 days prior to the first AI-061 administration for monoclonal antibody therapy. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, blood transfusion, and therapy for non-cancer conditions are allowed.
• 2\. Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent other systemic cancer therapeutics.
• 3\. Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent within 7 days before the first treatment.
• 4\. Patients who have active brain metastases or leptomeningeal metastases. 5. Patients who have an active infection requiring systemic IV antibiotics within 14 days prior to administration of AI-061. Regular treatment of urinary tract infection (UTI) and/or topical treatment are allowed.

Other illness

• 7\. Patients with known psychiatric or substance abuse disorders that in the opinion of the investigator, would interfere with cooperation with the requirements of the trial.
• 9\. Patients with active autoimmune diseases that require immunosuppressant treatment other than 10 mg per day or lower prednisone. Patients with inflammatory bowel disease or myasthenia gravis will be excluded.

Lab values

• 6\. Patients who, in the opinion of the treating Investigator, have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or make study participation not in the best interest of the patient. The investigator should discuss this with the Sponsor.

Other

• 8\. Patients who are pregnant or breastfeeding.

• 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).
  • Malignant lymph nodes: greater than or equal to 15 mm in short axis when assessed by CT scan (CT scan slice thickness must be \<5 mm). The measurement should be two dimensions at axial plane. The short axis should be in perpendicular to long diameter.
• 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.
• Male patient: agreement on contraceptive methods.
• Life expectancy greater than or equal to 12 weeks.