CYCC - Dosing underway in Cyclacel Pharma's Phase 1/2 study of oral fadraciclib in solid tumors and lymphomas

Cyclacel Pharmaceuticals (CYCC) announces dosing of the first patient in its multi-cohort Phase 1/2 study of oral fadraciclib in patients with advanced solid tumors. The Phase 1/2 registration-directed trial (CYC065-101) uses a streamlined design and will first determine the recommended Phase 2 dose (RP2D) for single-agent, oral fadraciclib.Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design, where single agent fadraciclib will be administered to patients in up to eight cohorts.The cohorts will include patients with breast cancer, colorectal, endometrial, hepatocellular and ovarian cancers, as well as certain lymphomas.An additional basket cohort will enroll patients with biomarkers relevant to the drug’s mechanism, including MCL1, MYC and cyclin E, regardless of histology.The protocol allows for expansion of a cohort based on response which may allow acceleration of the clinical development and registration plan for fadraciclib.

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Dosing underway in Cyclacel Pharma's Phase 1/2 study of oral fadraciclib in solid tumors and lymphomas