ONO-7018

P1, N=24, Not yet recruiting, Ono Pharmaceutical Co. Ltd

P1, N=108, Recruiting, Ono Pharmaceutical Co. Ltd | N=54 --> 108

For example, BTK C481S mutation is well known as a resistant mutation to covalent BTK inhibitors and several mutations of BTK (such as T474I and L528W mutation) have recently been reported in relapsed or refractory CLL patients with acquired resistance to pirtobrutinib, a non-covalent BTK inhibitor...ONO-7018 and tirabrutinib were orally administered to the mice twice a day... ONO-7018 would provide novel therapeutic strategies to overcome the BTK inhibitor acquired resistance and enhance the antitumor effect of BTK inhibitors in clinic. Phase 1 study of ONO-7018 (NCT05515406) is currently ongoing.

P1, N=54, Recruiting, Ono Pharmaceutical Co. Ltd | Not yet recruiting --> Recruiting

Conclusion The results from these translational research studies support the preparation of a clinical trial by clearly defining patient stratification biomarkers, combination strategies, and PD monitoring. These data underscore the potential therapeutic impact of ONO-7018 as a single-agent or combination partner with other inhibitors like BTK inhibitor and elucidate the sensitivity and response of ONO-7018 for the treatment of malignant lymphomas.

P1, N=54, Not yet recruiting, Ono Pharmaceutical Co. Ltd

In summary, the novel, selective, small-molecule MALT1 inhibitor CTX-177 demonstrated preclinical efficacy along with target engagement in several lymphoma models with activated antigen receptor signaling and NF-κB pathway. Our results underscore the preclinical therapeutic potential of CTX-177 as a single-agent or in combination with other inhibitors like BTK inhibitor for the treatment of malignant lymphomas.