Study of Oral Emavusertib Alone or With Ibrutinib in Adults with Relapsed or Refractory Primary Central Nervous System Lymphoma

What this Trial Is About

Researchers are evaluating the safety, how the body processes the drugs pharmacokinetics, and the anti-cancer effects of oral emavusertib alone or combined with ibrutinib in adults with relapsed or refractory blood cancers, specifically primary central nervous system lymphoma PCNSL. This multi-center, open-label trial includes several parts to study these treatments in different patient groups, including those who have progressed after previous therapies and those new to certain treatments. The study is sponsored by Curis, Inc. and spans from initial dose-finding to assessing response rates and safety. The trial is conducted in four parts. Part A1 involved increasing doses of emavusertib alone to find a safe dose. Part A2 tested emavusertib combined with ibrutinib at specified doses. Part B includes two groups of participants with PCNSL who progressed on a Bruton tyrosine kinase inhibitor BTKi, receiving emavusertib at either 100 mg or 200 mg twice daily plus ibrutinib daily in 28-day cycles. Part C involves three groups of participants with PCNSL new to BTKi treatment, randomly assigned to emavusertib alone, ibrutinib alone, or their combination, with treatment cycles of 28 days continuing as tolerated. Participants will take study drugs orally and undergo regular monitoring for safety and treatment effects. Researchers will evaluate side effects, determine maximum tolerated doses, and measure response rates and durations. Pharmacokinetic profiles of both drugs will be assessed over months. The trial includes assessments of tumor progression and survival, with follow-ups lasting up to several years. Participants health status and response to treatment will be carefully tracked throughout the study.

CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)