Endeavor Doses First Patient in Phase 2 Oncology Study Evaluating the Safety and Efficacy of ENV-101 (Taladegib)
Open-Label Trial in Patients with Advanced Solid Tumors Harboring PTCH1 Loss of Function Mutations
Excerpt from the Press Release:
SAN DIEGO–(BUSINESS WIRE)–Endeavor BioMedicines, a clinical-stage biotechnology company targeting the core drivers of terminal diseases including oncology and fibrosis, today announced the first patient has been dosed in an open-label Phase 2 study evaluating ENV-101 (taladegib) in patients with advanced solid tumors harboring Patched-1 (PTCH1) loss of function mutations
Dosing the first patient in the Phase 2 study of ENV-101 is a critical step for advancing medicines that treat cancer by attacking the genetic cause of disease,” said John Hood, Ph.D., Co-Founder, CEO and Chairman of Endeavor BioMedicines. “The clinical effects of ENV-101, a small molecule inhibitor of the Hedgehog signaling pathway for the treatment of cancer have been evaluated in nearly 200 participants so far. ENV-101 has so far demonstrated exceptional ability to inhibit this oncogenic pathway and induce regression of tumors dependent on it. We hope this trajectory will continue as the drug advances through this next stage of clinical development.”
The multi-center study employs a two-stage design to evaluate the efficacy and safety of ENV-101, a potent Hedgehog (Hh) pathway inhibitor, in patients with histologically or cytologically confirmed refractory advanced solid tumors characterized by loss of function (LOF) mutations in the PTCH1 gene. Endeavor expects to enroll 44 adults who are 18 and older in the first part of the study. Patients will receive 200 mg of ENV-101 once a day in one arm of the trial, and 300 mg of ENV-101 once a day in the other arm. The primary endpoint of the trial is Objective Response Rate (ORR) – comprised of Complete Response (CR) and Partial Response (PR), measured by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) – as determined by an independent review through study completion. Confirmed CR or PR will be defined as a repeat assessment performed no less than 28 days after the criteria for response is first met.
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