Phase 1b Study of Oral Adrixetinib Q702 to Assess Safety and Effects in Adults with Active Chronic Graft-Versus-Host Disease Who Have Relapsed or Are Resistant to Treatment

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Adrixetinib Q702 in adults with relapsed or refractory active chronic graft-versus-host disease cGVHD. This is an open-label, phase 1b dose escalation study focusing on patients who have moderate to severe active cGVHD requiring systemic immune suppression and who have not responded to standard treatments. Participants will receive escalating oral doses of Adrixetinib in 28-day treatment cycles. The study monitors dose-limiting toxicities and adverse events during the first cycle to assess safety and tolerability. Pharmacokinetic data will also be collected during this period to understand how the drug is processed in the body. Throughout the study, participants will be evaluated for treatment-related side effects and response to therapy. Researchers will use the NIH 2014 consensus criteria and other assessments to monitor disease progression and activity. The study includes safety monitoring of adverse events and serious adverse events, with involvement lasting as per the treatment cycles and follow-up defined by the study protocol.

A Study to Evaluate Adrixetinib (Q702) in Adults With Active Chronic Graft-Versus-Host Disease