First in Human, Dose Escalation, Dose Expansion Study of AUR105
Trial Parameters
Brief Summary
This is a multi-center, open-label, First in Human, Phase 1 study of AUR 105 in adult patients with advanced malignancies. The study will have two parts: a Dose Escalation Part and Dose Expansion Part.
Eligibility Criteria
Inclusion Criteria: * Males and females ≥ 18 years of age * Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 * Acceptable bone marrow and organ function at screening as described below: ANC ≥ 1500/μL (without WBC growth factor support) Platelet count ≥ 100,000/μL without transfusion support (Patients with lymphoma are allowed with Platelet count ≥ 75,000 / μL) Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb) 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 \[kg\] × \[0.85 if Female\] / \[72 × serum creatinine (mg/dL)\]). * Ability to swallow and retain oral medicatio