On February 8, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that the first patient has been dosed in a Phase 2 expansion cohort study of CYT-0851 monotherapy that is part of the Phase 1/2 trial. CYT-0851 is being evaluated for the treatment of hematologic malignancies and solid tumors (Press release, Cyteir Therapeutics, FEB 8, 2022, View Source [SID1234607863]).
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"We are excited to dose the first patient in the Phase 2 expansion cohort study with CYT-0851. This signal-seeking study in six different cancers will give us the data that may allow us to advance CYT-0851 into a clinical trial with potential registrational intent as soon as early next year," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "I am grateful to the entire Cyteir team, our investigators and participating patients as we work together to complete these expansion cohorts."
CYT-0851 Phase 2 Monotherapy Study
CYT-0851 is a potent and selective, oral investigational drug that was designed to inhibit RAD51-mediated homologous recombination and the repair of double-strand DNA breaks. For the Phase 2 monotherapy expansion cohort study with CYT-0851 (NCT Number NCT03997968), we intend to enroll in six disease-specific cohorts in hematologic malignancies (relapsed and/or refractory diffuse large B-cell lymphoma, follicular lymphoma, and multiple myeloma) and solid tumors (recurrent metastatic or locally advanced pancreatic cancer, progressive ovarian cancer, and metastatic soft tissue sarcoma).
The Phase 2 study is being run with a Simon two-stage design and patients will be dosed with the recommended Phase 2 dose of CYT-0851 of 400 mg once daily that was determined in the Phase 1 dose escalation study. The objectives of the expansion cohort study are to evaluate preliminary anti-tumor activity in each disease specific expansion cohort, and to confirm the safety of the chosen Phase 2 dose.