A Study of CUSP06 in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
Trial Parameters
Brief Summary
This phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of CUSP06 in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: * Written informed consent provided prior to any screening procedures. * Male or female patients, ≥18 years of age at the time of obtaining informed consent. * Patients with histologically or cytologically confirmed advanced solid tumors previously treated with standard of care systemic therapy, or for whom no standard therapy is available. * Willingness to provide archival tumor tissue, when available. If no archival tissue is available, willingness to undergo a pretreatment biopsy if medically feasible and safe. * Measurable disease per RECIST v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and life expectancy of ≥12 weeks. * Adequate organ function as defined by: * Absolute neutrophil count (ANC) ≥1.5 x 109/L (1500/µL), without colony-stimulating factor support for the past 14 days. * Platelets ≥100.0 x 109/L (100 000/µL). * Hemoglobin ≥9.0 g/dL (without blood transfusion in 2-week period prior to screening). * Creatinine clearance