Curis Doses First Patient In Phase 1 Study Of CA-4948

Curis Inc. (CRIS) said that the first patient has been dosed in its Phase 1 trial evaluating CA-4948, a novel, small molecule IRAK4 kinase inhibitor, in combination with ibrutinib, a BTK inhibitor, in patients with relapsed or refractory (R/R) hematologic malignancies. The initial data are expected in the fourth quarter of 2021.

According to the company, the Phase 1 trial is a two-part, multicenter, open-label, dose escalation and expansion study. Part 1 of the study is a dose escalation using a 3+3 design. About 18 patients will be enrolled in Part 1 and will receive a starting dose of 200mg CA-4948 BID with subsequent escalation to 300mg BID, both of which have been observed to be safe and effective in the NHL monotherapy study, combined with ibrutinib doses appropriate for their respective NHL subtype.

Part 2 of the study will enroll patients across an expansion basket of four cohorts: marginal zone lymphoma (MZL), ABC-DLBCL, primary central nervous system lymphoma (PCNSL), and NHL with adaptive ibrutinib resistance.

The company noted that an interim futility analysis will be conducted after approximately 15-20 patients are enrolled in each cohort.

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