Phase 1 CS231295 Aurora B–selective multi-kinase inhibitor in advanced solid tumors and glioma

This Phase 1, single-arm, open-label, multicenter dose-escalation study evaluates CS231295 in adults with unresectable, advanced/recurrent/metastatic solid tumors (including a glioma cohort) who have exhausted available standard options. CS231295 is an oral, brain-penetrant Aurora kinase B (AURKB)–selective inhibitor (described as AURKB-biased multi-kinase), aiming to disrupt mitosis and tumor cell proliferation; the program also highlights potential sensitivity in RB1-deficient tumors (a common biology in small cell lung cancer) and intracranial activity as a differentiator for CNS disease. ThalassaX Therapeutics United States Ltd is listed as the sponsor for this US trial, while public company materials and reporting link CS231295’s discovery/development to Chipscreen Biosciences. The design includes sequential 3–6 patient cohorts with safety/PK-driven escalation and an initial single-dose lead-in followed by 28-day continuous dosing cycles until progression or toxicity. For these refractory populations, today’s care is tumor-specific and typically consists of remaining approved systemic options (chemotherapy, targeted therapy when actionable, immunotherapy when eligible) or best supportive care/clinical trials; for recurrent high-grade glioma, common approaches include repeat surgery when feasible, re-irradiation in select cases, temozolomide/lomustine-based regimens, bevacizumab for symptom control, and trials—so this tests whether a brain-penetrant mitotic kinase inhibitor can add meaningful activity where options are limited.