A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy

Korábbi kezelés

• Patients with a prior history of anticancer therapy before the first dose
• Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO
• Has prior treatment with duocarmycin-containing agents
• Prior allogenic bone marrow transplantation or solid organ transplantation
• History of autoimmune disease, treatment with systemic immunosuppressive medications

Más betegség

• History of another active malignancy within the past 3 years
• Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression.
• Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions.
• Tuberculosis with active disease
• Active infection necessitating systemic therapy
• Patients with clinically significant pulmonary disease

Egyéb

• Inability to comply with study and follow-up procedures
• Pregnancy, lactation, or breastfeeding

• Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)
• Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent.
• Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
• Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3)
• Patients who have received standard therapies and have no remaining clinically available approved treatment options.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Estimated life expectancy of ≥ 3 months