Extrait

Part 1: - Determination of MTD/MRD and tolerability - Evaluation of adverse events (AEs) and dose limiting toxicities (DLT) Part 2: Primary Safety End Point: - To characterize the safety and tolerability of MCLA-128 - Frequency and nature of AEs Primary Efficacy End Point: - To explore the relationships between the anti-tumor activity of MCLA128 and disease-related biomarkers - Overall response rate (ORR), DOR, CBR (defined as the proportion of patients in whom a CR or PR is observed, or SD of a minimum duration of 12 weeks) per RECIST 1.1 as per local investigator's assessment. The relationship between anti-tumor activity and biomarkers including expression of HER2, HER3, and heregulin will be explored, and serum biomarkers as CA-125 (ovarian) and CA-15-3 (breast).

Critère d'inclusion

• Solid Tumors

Liens

• euctr
• ictrp
• euctr
• ictrp
• euctr