Phase 12 Study of RNK05047 IV Infusion to Evaluate Safety and Effectiveness in Adults With Advanced Solid Tumors and Diffuse Large B-cell Lymphoma

What this Trial Is About

Researchers are evaluating RNK05047, a chaperone-mediated protein degrader, in adults with advanced solid tumors, including diffuse large B-cell lymphoma DLBCL. This Phase 12 open-label study aims to assess the safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and efficacy of RNK05047 when given as an intravenous infusion. The study involves dose escalation and expansion to determine the recommended dose and explore treatment effects in specific tumor types. In the first part, participants receive weekly IV infusions of RNK05047 for three weeks followed by one week off in each 4-week cycle. The dose is gradually increased following a standard 33 design starting at 0.75 mgkg. The second part enrolls additional participants in expansion cohorts based on results from the dose escalation phase, with about 15 subjects per cohort. These cohorts may run concurrently and focus on tumor types guided by emerging data. Participants will undergo regular assessments including monitoring for dose-limiting toxicities DLTs, treatment-emergent adverse events TEAEs, and objective tumor responses using RECIST 1.1RECIL 2017 criteria over approximately one year. Blood samples will measure drug levels during early cycles. The study also tracks progression-free survival, duration of response, disease control rate, and overall survival. Safety and treatment effects are closely observed throughout the study duration.

A Study of RNK05047 in Subjects With Advanced Solid Tumors/Diffuse Large B-cell Lymphoma (CHAMP-1)