On January 10, 2019 Tolero Pharmaceuticals, Inc., a clinical-stage company focused on developing novel therapeutics for hematological and oncological diseases, reported that the first patient has been dosed in a Phase 1 study evaluating the investigational agent TP-1287, an oral cyclin-dependent kinase 9 (CDK9) inhibitor, in patients with advanced solid tumors (Press release, Tolero Pharmaceuticals, JAN 10, 2019, View Source [SID1234532624]). The open-label, dose-escalation, safety, pharmacokinetics, and pharmacodynamic study will evaluate the maximum tolerated dose and dose-limiting toxicities of TP-1287 administered in patients with advanced solid tumors.
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"The initiation of this study is an important step forward in understanding the potential of TP-1287 in patients with solid tumors," said David J. Bearss, Ph.D., Chief Executive Officer of Tolero Pharmaceuticals. "We believe that the oral administration of TP-1287 may be beneficial in disease settings where this form of administration is preferred or when used in combination with other targeted agents."
The primary objective of the Phase 1 study is to determine the maximum tolerated dose and dose-limiting toxicities of oral TP-1287 administration in patients with advanced solid tumors. The study is being conducted at sites in the United States. Additional information on this trial, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT03604783).
About TP-1287
TP-1287 is an investigational oral cyclin-dependent kinase 9 (CDK9) inhibitor entering into a Phase 1 study in patients with advanced solid tumors (NCT03604783). TP-1287 has shown favorable oral bioavailability in preclinical models.