Study of CBA-1205 Antibody for Advanced Solid Tumors, Liver Cancer, Melanoma, and Pediatric Cancers Evaluating Safety and Tolerability

What this Trial Is About

Researchers are evaluating CBA-1205, an anti-DLK1 monoclonal antibody, in a first-in-human Phase I study involving patients with advanced solid tumors, hepatocellular carcinoma HCC, malignant melanoma, and pediatric cancers. The study aims to assess the safety and tolerability of CBA-1205 across five parts, including dose escalation and evaluation in different patient groups where standard treatments are unavailable or ineffective. This trial is conducted at multiple centers and is non-randomized and open-label. Participants receive CBA-1205 intravenously at two-week intervals in 28-day cycles. The study includes seven dose cohorts ranging from 0.1 mgkg to 30 mgkg for solid tumors in Part 1, with subsequent parts focusing on specific cancers such as HCC, melanoma, and pediatric cancers. Treatment continues until criteria for discontinuation are met. Pharmacokinetic analysis is also part of the evaluation. During the study, participants will undergo safety monitoring for dose-limiting toxicities and adverse events up to 12 months. Blood samples will be collected to measure serum drug concentration and immunogenicity. Efficacy assessments occur at screening, during treatment cycles, and until treatment discontinuation. Overall, participant involvement includes regular visits for treatment administration and comprehensive monitoring throughout the study duration.

A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer