A Phase 1 Clinical Trial of AUR106 in Patients With Relapsed Advanced Malignancies

Inclusion Criteria

• •1. Provide signed and dated informed consent and agree to comply with all study related activities.
• •2. Male or female patients aged ≥ 18 years.
• •3. Patients have to meet the following criteria:
• •* Pathological diagnosis of the following solid tumors: Non-small cell lung cancer, Gastric cancer, Urothelial cancer (includes bladder cancer and cancers of ureter / renal pelvis), Kidney cancer, Colon cancer, Esophageal cancer).
• •* Standard curative or life prolonging measures do not exist, and patient must have exhausted all effective therapies, available locally. At a minimum, patients should have received at least 2 lines of therapy in the metastatic setting.
• •* Standard treatment options provided to the patients are exhausted.
• •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Patients with disease related ECOG 2 are allowed, in addition to ECOG 0 and 1).
• •5. Acceptable bone marrow as described below:
• •* ANC ≥ 1500/μL (without WBC growth factor support).
• •* Platelet count ≥ 100,000/μL without transfusion support.
• •* Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb).
• •6. Acceptable organ function as described below:
• •* Total Bilirubin ≤ 1.5 x ULN (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN).
• •* AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases).
• •* ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases).
• •* Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine clearance \[eCrCl\]: eCrCl = \[140 - Age\] × Weight \[kg\] × \[0.85 if Female\] / \[72 × serum creatinine (mg/dL)\]).
• •* Albumin ≥ 3.0 g/dL.
• •7. Ability to swallow and retain oral medications.
• •8. Negative serum pregnancy test in women of childbearing potential (WOCBP).
• •9. Women of childbearing potential and men who partner with such a woman of childbearing potential must agree to use one or more of highly effective method(s) of contraception for the duration of the study, i.e., through 28-day follow up visit, after discontinuation of study drug(s).
• •10. Evidence of measurable disease per RECIST, v1.1 for solid tumors (Eisenhauer et al. 2009). Measurable disease for solid tumors is defined as at least one lesion that can be accurately measured in at least 1 dimension with a minimum size of 10 mm for non-nodal lesions or 15 mm in short axis for nodal lesions.
• •13. Pregnant or lactating women.
• •14. Any clinically significant medical, psychiatric or social condition; or laboratory abnormality that may increase the risk of trial participation or may interfere with the informed consent process and/or with compliance with the requirements of the trial or may interfere with the interpretation of the trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.
• •15. Patients who require concomitant administration of drugs which have a high risk of prolonging QT interval.