A Phase 1 Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OCT-598 as a Single Agent and in Combination With Standard-of-Care Treatment in Patients With Advanced Solid Tumors
This is a Phase 1 study intended to determine the MTD of OCT-598 following multiple-dose therapy and to establish the RP2D for OCT-598 as a single agent, by assessing its safety and tolerability as monotherapy and in combination with standard-of-care treatments in patients with advanced solid tumors.
• Female or male, ≥18 years of age (or ≥19 years according to according to the local regulatory guidance), at the time of screening
• Signed informed consent prior to any study-related procedures that are not considered standard of care
• Life expectancy \>12 weeks in the opinion of the investigator
• Adequate organ and marrow function, defined as follows:
‣ Absolute neutrophil count ≥1.5 × 109/L
⁃ Platelets ≥100,000/μL
⁃ Hemoglobin ≥9.0 g/dL
⁃ Total bilirubin \<1.5 × ULN
⁃ ALT or AST ≤2.5 × ULN
⁃ Creatinine clearance calculated using the Cockcroft-Gault formula ≥60 mL/min (In equivocal cases, a 24-hour urine collection test can be used to estimate the creatinine clearance more accurately)
• LVEF \>50% or within institutional values
• At least 1 measurable lesion based on RECIST version 1.1
• Cohort-specific disease requirements:
∙ Part A: patients with advanced solid tumors and no effective standard therapy option or for whom standard-of-care treatment is not available or not appropriate as per the investigator's discretion
‣ Part B: patients with advanced solid tumors who are candidates for receiving docetaxel as a single agent for their cancer treatment, including but not limited to: advanced human epidermal growth factor receptor 2-negative breast cancer, recurrent/metastatic head and neck cancer, non-small cell lung cancer, prostate cancer, or gastric/gastroesophageal cancer
• Docetaxel-appropriate (Part B): patients who have not received prior docetaxel in the advanced setting are eligible