XL092 is a next-generation oral tyrosine kinase inhibitor that targets VEGF receptors, MET, and other kinases implicated in cancer's growth and spread. The molecule is the subject of an active Investigational New Drug application Exelixis submitted to the US Food and Drug Administration in December 2018.
This multi-center phase 1 clinical trial is designed to evaluate the pharmacokinetics, safety and tolerability of XL092. The trial is divided into dose-escalation and expansion phases.
The dose-escalation phase of the trial will enroll patients with advanced solid tumors, with the primary objective of determining a dose for daily oral administration of XL092 suitable for further evaluation.
Assuming positive data from the initial phase of the trial, the expansion phase is designed to further explore the selected dose of XL092 in individual tumor cohorts, where safety, tolerability, and initial clinical activity would be evaluated.
Founded in 1994, Exelixis, Inc. (NASDAQ: EXEL) is an oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialisation of new medicines for difficult-to-treat cancers.
Its discovery efforts have resulted in four approved products, Cabometyx (cabozantinib), Cometriq (cabozantinib), Cotellic (cobimetinib) and Minnebro (esaxerenone), and it has entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide.
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Portage Biotech expands evaluation of strategic alternatives
Stamford Pharmaceuticals starts locally advanced basal cell carcinoma (laBCC) trial of SP-002
QST selects RayStation for advanced carbon ion therapy
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Innate Pharma reports preclinical efficacy of IPH45
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
enGene Holdings names new senior vice president, Urologic Oncology and Clinical Development
CLS secures second order from NIH Clinical Center for Thermal Therapy System accessories