Onconova -Narazaciclib - Multi-kinase Inhibitor (ON 123300)
Narazaciclib (ON 123300) is a multi-kinase inhibitor targeting CDK 4/6 and additional kinases involved in tumor genesis, which the Company believes presents an innovative approach to treating advanced cancers including HR+ HER2- metastatic breast cancer that is, or has become, resistant to commercial CDK 4/6 inhibitors. Beyond metastatic breast cancer, the Company believes that narazaciclib (ON 123300) may also present an innovative approach to treating other cancers including mantle cell lymphoma, multiple myeloma, advanced colorectal cancer, hepatocellular carcinoma and inoperable glioblastoma.
Narazaciclib (ON 123300) in Patients with Advanced Solid Tumors
Phase 1 in US (NCT04739293)
This is an exploratory Phase 1 study to assess the safety, tolerability, and pharmacokinetics of narazaciclib (ON 123300) capsules administered orally as escalating daily doses in patients with advanced cancer relapsed or refractory to at least one (1) prior line of therapy.
Status: Recruiting
Narazaciclib (ON 123300) in Patients with Advanced Solid Tumors
Phase 1 in China
This is an open-label, dose-escalating Phase 1 study to study the safety and tolerability of narazaciclib (ON 123300) in patients with advanced solid tumors who have failed on prior therapies. An expansion cohort of breast and lung cancer patients will be enrolled at the recommended Phase 2 dose.
Status: Recruiting