Study to Assess the Effect of OCT-598 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.
| Condition(s) | Solid Tumor, Breast Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Gastric/Gastroesophageal Junction Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Oscotec Inc. |
| Locations | Goyang-si, South Korea; Seongnam-si, South Korea; Seoul, South Korea |
| Start date | 2025-12-18 |
| NCT ID | NCT07358806 |
| Official listing | https://clinicaltrials.gov/study/NCT07358806 |